US Market News
2月前
Findings From Long-Term Analysis of the Effects of LYBALVI® (olanzapine and samidorphan) on Negative Symptoms of Schizophrenia Published in The Journal of Clinical PsychiatryApril 14, 2026 7:00 AM
Business Wire
— 56-Week Post Hoc Analysis Demonstrated Sustained Reduction in Hard-to-Treat Negative Symptoms —
Alkermes plc (Nasdaq: ALKS) today announced the publication of a 56-week post hoc analysis of the effects of LYBALVI® (olanzapine and samidorphan) on negative symptoms in adults living with schizophrenia in the peer-reviewed publication The Journal of Clinical Psychiatry. The analysis—titled “The Efficacy of Olanzapine/Samidorphan on Negative Symptoms: A Post Hoc Analysis of 56-Week Treatment in Patients With Schizophrenia”—found that treatment with LYBALVI was associated with improvement in mean negative symptom scores. LYBALVI is approved in the U.S. for the treatment of schizophrenia in adults, and for the treatment of bipolar I disorder in adults, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or as adjunct to lithium or valproate. The full manuscript is now accessible online.
In schizophrenia, “positive symptoms” refer to an excess or distortion of normal function (such as delusions, hallucinations and disorganized thinking) while “negative symptoms” refer to a reduction or absence of normal behaviors (blunted affect, reduction in quantity of words spoken, reduced goal-directed activity due to decreased motivation, emotional or social withdrawal and diminished ability to experience pleasure). Negative symptoms are often associated with reduced functioning in patients with schizophrenia and can be a predictor of poor treatment response; addressing them remains a treatment challenge in schizophrenia.1,2
“Publication of this negative symptom post hoc analysis adds to a growing body of evidence supporting the role of LYBALVI in treating the complex symptomology related to schizophrenia,” said Craig Hopkinson, M.D. (MBChB), Chief Medical Officer and Executive Vice President, Research & Development at Alkermes. “Alkermes remains committed to expanding the field’s understanding of this challenging disease and the impact of medicine in helping patients manage their illness. We look forward to continued engagement with the scientific community in this important discourse.”
Data from the post hoc analysis were derived from 281 adults who completed ENLIGHTEN-1—a 4-week inpatient study evaluating the efficacy, safety and tolerability of LYBALVI compared to olanzapine and placebo in patients experiencing an acute exacerbation of schizophrenia—and who subsequently enrolled in a 52-week open-label extension study (ENLIGHTEN-1 Extension) in which all patients received LYBALVI. Patient symptoms were assessed using the 30-item Positive and Negative Syndrome Scale (PANSS). This analysis looked at several subscales of the PANSS, including Negative Symptoms, Positive Symptoms and General Psychopathology Subscale scores and the Marder Negative Factor scores. LYBALVI demonstrated improvements from baseline in all subscale scores. In addition, the analysis looked at changes in two subgroups: in patients with prominent negative symptoms* (n=186) at baseline and in patients with predominant negative symptoms**/low positive symptoms (n=48) at baseline, in order to ascertain if the changes in negative symptoms were driven by changes in positive symptoms.
The analysis showed decreased negative symptoms over the first four weeks in a pooled analysis of treatment arms (LYBALVI, olanzapine and placebo) in ENLIGHTEN-1 with continued improvement over the 52 weeks of open-label treatment with LYBALVI.
Baseline scores: The mean PANSS Negative Symptoms Subscale score at baseline was 25.7 and the mean Marder Negative Factor score at baseline was 25.2 in patients overall. The mean Marder Negative Factor score at baseline was 27.7 in the prominent negative symptoms subgroup and 28.2 in the predominant negative symptoms subgroup.
Patients overall: Least squares (LS) mean changes from baseline in PANSS Negative Symptoms Subscale scores among all patients were -4.1 at week 4 and -7.6 at week 56. LS mean changes from baseline in Marder Negative Factor scores among all patients were -4.5 at week 4 and -8.2 at week 56.
Prominent subgroup: Among patients with prominent negative symptoms at baseline, LS mean changes from baseline in PANSS Negative Symptoms Subscale scores were -4.6 at week 4 and -8.7 at week 56, and LS mean changes in Marder Negative Factor scores were -5.0 at week 4 and -9.6 at week 56.
Predominant subgroup: A similar pattern of change was observed among patients with predominant negative symptoms at baseline. LS mean changes from baseline in Marder Negative Factor scores across patients in this subgroup were -4.7 at week 4 and -8.9 at week 56.
According to study author Christoph U. Correll, M.D., Professor of Psychiatry at The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, “LYBALVI has already been shown to provide the established efficacy of olanzapine as measured by PANSS total scores while mitigating olanzapine-associated weight gain and its effects on positive symptoms of schizophrenia have been evaluated. This post hoc analysis of the effect of LYBALVI on negative symptoms, which remain a persistent treatment challenge, further validates LYBALVI’s utility for the treatment of schizophrenia, a condition characterized by complex symptom domains.”
* Patients with prominent negative symptoms were defined as having a baseline Marder Negative Factor score ≥24.
** Patients with predominant negative symptoms/low positive symptoms were defined as having a baseline Marder Negative Factor score ≥24, PANSS scores ≥4 on two of the negative symptom items, and a PANSS Mohr Positive Factor score ≤19.
About Schizophrenia
Schizophrenia is a serious brain disorder marked by positive symptoms (hallucinations and delusions, disorganized speech and thoughts, and agitated or repeated movements) and negative symptoms (depression, blunted emotions and social withdrawal).3 Schizophrenia affects approximately 1.1% of the U.S. population.4
About the Post Hoc Analysis of the ENLIGHTEN-1 and ENLIGHTEN-1 Extension Studies
This post hoc analysis examined data from patients who completed the ENLIGHTEN-1 study, a 4-week, placebo- and olanzapine-controlled study of LYBALVI for the treatment of acute schizophrenia, and who had at least one PANSS assessment in the 52-week, open-label ENLIGHTEN-1 Extension study in which all patients received LYBALVI. The analysis assessed the effects of up to 56 weeks of LYBALVI treatment on negative symptoms by integrating data across both studies. For the evaluation of the initial four weeks of treatment, data from the LYBALVI, placebo, and olanzapine treatment arms in ENLIGHTEN-1 were combined. Interpretation of the findings from this analysis is limited by the absence of a control group in ENLIGHTEN-1 Extension and by the fact that only patients meeting the ENLIGHTEN-1 enrollment criteria, specifically those initially experiencing an acute exacerbation of schizophrenia, were included. Additionally, the number of patients who met the criteria for predominant negative symptoms was relatively small.
About LYBALVI® (olanzapine and samidorphan)
LYBALVI® (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug approved in the U.S. for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate. LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist, in a single bilayer tablet. LYBALVI is available in fixed dosage strengths composed of 10 mg of samidorphan and 5 mg, 10 mg, 15 mg or 20 mg of olanzapine.
INDICATIONS AND IMPORTANT SAFETY INFORMATION for LYBALVI® (olanzapine and samidorphan)
INDICATIONS
LYBALVI is indicated for the treatment of:
Schizophrenia in adults
Bipolar I disorder in adults
— Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate
— Maintenance monotherapy treatment
IMPORTANT SAFETY INFORMATION
Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LYBALVI is not approved for the treatment of patients with dementia-related psychosis.
Contraindications: LYBALVI is contraindicated in patients who are using opioids or are undergoing acute opioid withdrawal. If LYBALVI is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for the contraindications for these products.
Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke, transient ischemia attack, and fatalities. See Boxed Warning.
Precipitation of Severe Opioid Withdrawal in Patients who are Physiologically Dependent on Opioids: LYBALVI can precipitate opioid withdrawal in patients who are dependent on opioids, which can lead to an opioid withdrawal syndrome, sometimes requiring hospitalization. LYBALVI is contraindicated in patients who are using opioids or undergoing acute opioid withdrawal. Prior to initiating LYBALVI, there should be at least a 7-day opioid-free interval from last use of short-acting opioids, and at least a 14-day opioid-free interval from the last use of long-acting opioids. Explain the risks associated with precipitated withdrawal and the importance of giving an accurate account of last opioid use to patients and caregivers.
Vulnerability to Life-Threatening Opioid Overdose: Attempting to overcome opioid blockade with high or repeated doses of exogenous opioids could lead to life-threatening or fatal opioid intoxication, particularly if LYBALVI therapy is interrupted or discontinued, subjecting the patient to high levels of unopposed opioid agonist as the samidorphan blockade wanes. Inform patients of the potential consequences of trying to overcome the opioid blockade and the serious risks of taking opioids concurrently with LYBALVI or while transitioning off LYBALVI. In emergency situations, if a LYBALVI-treated patient requires opioid treatment as part of anesthesia or analgesia, discontinue LYBALVI. Opioids should be administered by properly trained individual(s) and patient should be continuously monitored in a setting equipped and staffed for cardiopulmonary resuscitation. Patients with a history of chronic opioid use prior to treatment with LYBALVI may have decreased opioid tolerance if LYBALVI therapy is interrupted or discontinued. Advise patients that this decreased tolerance may increase the risk of opioid overdose if opioids are resumed at the previously tolerated dosage.
Neuroleptic Malignant Syndrome, a potentially fatal reaction. Signs and symptoms include hyperpyrexia, muscle rigidity, delirium, autonomic instability, elevated creatine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation, intensive symptomatic treatment, and close monitoring.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), a potentially fatal condition reported with exposure to olanzapine, a component of LYBALVI. Symptoms include a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. Discontinue if DRESS is suspected.
Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Any patient treated with LYBALVI should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required anti-diabetic treatment despite discontinuation of the suspect drug. Measure weight and assess fasting glucose and lipids when initiating LYBALVI and monitor periodically.
Tardive Dyskinesia (TD): Risk of developing TD (a syndrome of potentially irreversible, involuntary, dyskinetic movements) and the likelihood it will become irreversible increases with the duration of treatment and the cumulative dose. The syndrome can develop after a relatively brief treatment period, even at low doses, or after discontinuation. Given these considerations, LYBALVI should be prescribed in a manner that is most likely to reduce the risk of tardive dyskinesia. If signs and symptoms of TD appear, drug discontinuation should be considered.
Orthostatic Hypotension and Syncope: Monitor orthostatic vital signs in patients who are vulnerable to hypotension, patients with known cardiovascular disease, and patients with cerebrovascular disease.
Falls: LYBALVI may cause somnolence, postural hypotension, and motor and sensory instability, which may lead to falls, and consequently, fractures or other injuries. Assess patients for risk when using LYBALVI.
Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases): Perform complete blood counts in patients with a history of a clinically significant low white blood cell (WBC) count or history of leukopenia or neutropenia. Discontinue LYBALVI if clinically significant decline in WBC occurs in the absence of other causative factors.
Dysphagia: Use LYBALVI with caution in patients at risk for aspiration.
Seizures: Use LYBALVI with caution in patients with a history of seizures or with conditions that lower the seizure threshold.
Potential for Cognitive and Motor Impairment: Because LYBALVI may cause somnolence, and may impair judgment, thinking, or motor skills, caution patients about operating hazardous machinery, including motor vehicles, until they are certain that LYBALVI does not affect them adversely.
Body Temperature Dysregulation: Use LYBALVI with caution in patients who may experience conditions that increase core body temperature (e.g., strenuous exercise, extreme heat, dehydration, or concomitant use with anticholinergics).
Anticholinergic (Antimuscarinic) Effects: Olanzapine, a component of LYBALVI, was associated with constipation, dry mouth, and tachycardia. Use LYBALVI with caution with other anticholinergic medications and in patients with urinary retention, prostatic hypertrophy, constipation, paralytic ileus or related conditions. In postmarketing experience, the risk for severe adverse reactions (including fatalities) was increased with concomitant use of anticholinergic medications.
Hyperprolactinemia: LYBALVI elevates prolactin levels. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.
Risks Associated with Combination Treatment with Lithium or Valproate: If LYBALVI is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for a description of the risks for these products.
Interference with Laboratory Tests for Opioid Detection: LYBALVI may cause false positive results with urinary immunoassay methods for detecting opioids. Use an alternative analytical technique (e.g., chromatographic methods) to confirm positive opioid urine drug screen results.
Most Common Adverse Reactions observed in clinical trials were:
Schizophrenia (LYBALVI): weight increased, somnolence, dry mouth, and headache
Bipolar I Disorder, Manic or Mixed Episodes (olanzapine): somnolence, dry mouth, dizziness, asthenia, constipation, dyspepsia, increased appetite, and tremor
Bipolar I Disorder, Manic or Mixed Episodes, adjunct to lithium or valproate (olanzapine): dry mouth, weight gain, increased appetite, dizziness, back pain, constipation, speech disorder, increased salivation, amnesia, paresthesia
Concomitant Medication: LYBALVI is contraindicated in patients who are using opioids or undergoing acute opioid withdrawal. Concomitant use of LYBALVI is not recommended with strong CYP3A4 inducers, levodopa and dopamine agonists. Reduce dosage of LYBALVI when using with strong CYP1A2 inhibitors. Increase dosage of LYBALVI with CYP1A2 inducers. Use caution with diazepam, alcohol, other CNS acting drugs, or in patients receiving anticholinergic (antimuscarinic) medications. Monitor blood pressure and reduce dosage of antihypertensive drug in accordance with its approved product labeling.
Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with LYBALVI. Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to LYBALVI during pregnancy.
Renal Impairment: LYBALVI is not recommended for patients with end-stage renal disease (eGFR of
US Market News
3月前
Alkermes plc Announces CEO Succession PlanFebruary 25, 2026 6:55 AM
Business Wire
— Richard Pops to Retire from Role of Chief Executive Officer Following Distinguished 35-year Career with Alkermes —
— Board of Directors Appointed Blair Jackson, Alkermes’ Current Executive Vice President, Chief Operating Officer, as CEO Effective as of August 1, 2026 —
— Richard Pops to Continue to Serve as Chairman of the Alkermes Board of Directors —
Alkermes plc (Nasdaq: ALKS) (Alkermes) today announced that Richard Pops will retire from his role as Chief Executive Officer (CEO), effective July 31, 2026. Alkermes’ Board of Directors (the Board) appointed Blair Jackson, Alkermes’ current Executive Vice President, Chief Operating Officer, as the company’s next CEO, effective Aug. 1, 2026. Mr. Jackson is also expected to join the Board at that time. Following the transition, Mr. Pops will continue to serve as Chairman of the Board and will act as an advisor to the company’s executive team.
Mr. Pops’ three decades of visionary leadership have shaped the company into a resilient, innovation-driven leader in neuroscience drug development. He joined Alkermes in 1991 as Chief Executive Officer, four years after the company was founded. Under his leadership, Alkermes has evolved from a nascent organization with 20 employees focused on technologies to deliver medicines through the blood-brain barrier into a leading commercial-stage biopharmaceutical drug development company recognized for its patient-centered mission, scientific ambition, and commitment to addressing some of the most complex challenges in neuroscience. Today, Alkermes has more than 2,000 employees and has generated annual revenues of approximately $1.5 billion, primarily driven by medicines developed and commercialized by Alkermes. In addition, the company is advancing multiple development candidates focused on orexin agonism, one of the most exciting new therapeutic categories in neuroscience, including alixorexton, which has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for treatment of narcolepsy type 1. Most recently, the company completed the acquisition of Avadel Pharmaceuticals plc (Avadel), adding an FDA-approved product in the sleep medicine market to Alkermes’ commercial portfolio and providing Alkermes with a commercial organization experienced in narcolepsy, enhancing the company’s ability to unlock the full potential of its late-stage development pipeline focused on central disorders of hypersomnolence.
“It has been a great honor to serve as CEO of Alkermes alongside so many dedicated colleagues over the years. From the beginning, the evolution of this company has been guided by science and driven by purpose—a commitment to follow the data, act with integrity, make a meaningful difference for patients, and create value for our shareholders. Together, we have built a company with a strong financial foundation, commercial medicines that have reached hundreds of thousands of patients with serious mental illness or addiction, and a compelling opportunity ahead in sleep medicine,” said Mr. Pops. “As I prepare to transition the CEO role to Blair later this year, I do so with immense pride in the company we’ve built and conviction in the company’s growth opportunity ahead. Blair has been a trusted partner to me for many years, and I have great confidence in his leadership as the company builds on its success in the neuroscience space. I look forward to continuing to support him and the organization in my continuing role as Chairman as we enter this next chapter.”
“Throughout Richard’s tenure, his leadership has been defined by strategic clarity, bold decision-making, an unwavering belief in the company’s potential and a profound commitment to some of the country’s most under-served patient populations. His vision shaped not only Alkermes’ strategy and portfolio, but also its culture of integrity, curiosity, and collaboration. The Board is grateful for Richard’s decades of leadership and his continued commitment to the company. We have full confidence in the strength of the organization Richard has built and its potential to continue on its growth trajectory under Blair’s leadership,” said Andy Wilson, Lead Independent Director of the Alkermes Board. “In preparation for this transition, the Board engaged in a thorough and rigorous succession planning process. With his broad skillset and deep knowledge of the business, we are confident that Blair is the right leader to guide Alkermes into its next chapter of growth and impact.”
Mr. Jackson has over 25 years of diverse scientific, operational and business strategy experience in the biopharmaceutical industry. As a key member of Alkermes’ senior executive team, Mr. Jackson has helped guide Alkermes through its recent transformation, contributing to the divestment of the company’s oncology business, the sale of its Athlone manufacturing facility and the acquisition of Avadel.
“I am honored to carry forward Alkermes’ legacy of working to address unmet needs of patients living with complex conditions in the neuroscience space. With a strong commercial business, an exciting pipeline, a deeply committed team, and a clear path for growth, I’m energized by the opportunities ahead to advance our pipeline, leverage our scientific leadership and create value for shareholders,” said Mr. Jackson. “I’ve had the privilege of working alongside Richard for more than twenty years and have learned a great deal from him as he carried out his vision to build Alkermes into the company it is today. I appreciate the Board’s confidence in me and look forward to working closely with them as we enter this next chapter.”
About Blair Jackson
Since joining Alkermes in 1999, Mr. Jackson has served in a variety of roles in both a scientific and corporate capacity. As Alkermes’ Executive Vice President, Chief Operating Officer, a position he has held since January 2021, Mr. Jackson is responsible for Alkermes’ strategic planning and corporate services, leading the organization’s global operations, quality, information technology, business development and corporate planning functions. Mr. Jackson also served as Interim Principal Financial Officer from February 2024 to September 2025.
Prior to assuming his current position, Mr. Jackson most recently served as Senior Vice President, Corporate Planning of Alkermes, Inc. from July 2018 to January 2021, responsible for business development and alliance management, business planning, new product planning, data analytics and market research and corporate operations functions.
Mr. Jackson currently serves on the Board of Directors of Synchronicity Pharma, Inc., a private clinical-stage biopharmaceutical company.
Mr. Jackson earned a bachelor’s degree in Biochemistry from the University of Calgary in Alberta, Canada, a bachelor’s degree in Chemical Engineering and a Master of Business Administration from the University of Alberta, and a Master of Science in Chemical Engineering from the Massachusetts Institute of Technology.
About Alkermes plc
Alkermes plc (Nasdaq: ALKS), a mid-cap growth and value equity, is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy. Alkermes’ pipeline includes late-stage clinical candidates in development for narcolepsy and idiopathic hypersomnia, and orexin 2 receptor agonists in early clinical development for other neurological disorders, including attention-deficit hyperactivity disorder (ADHD) and fatigue associated with multiple sclerosis and Parkinson’s disease. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company’s expectations concerning its future financial and operating performance, business plans or prospects, including expected drivers of growth and value creation and the anticipated benefits of the Avadel acquisition; the company’s expectations regarding the potential therapeutic and commercial value of its portfolio of development candidates; and the company's expectations with respect to the transition of the CEO role. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether the company is able to achieve its financial expectations, including those related to growth and value creation; the expected benefits and value of the Avadel acquisition may not be achieved; clinical development activities may not be initiated or completed on expected timelines or at all; the results of development activities may not be positive, or predictive of future results from such activities, results of future development activities or real-world results; the company’s products or product candidates could be shown to be ineffective or unsafe; the FDA or regulatory authorities outside the U.S. may not agree with the company’s regulatory approval strategies or may make adverse decisions regarding its products; the company may not be able to continue to successfully commercialize its products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company’s products or an increase in related financial obligations to government payers; the company’s products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; the company may not be able to attract and/or retain highly qualified members of its management team and other key clinical and scientific personnel; and those risks and uncertainties described under the heading “Risk Factors” in the company’s most recent Annual Report on Form 10-K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260224564610/en/
Alkermes:
For Investors: Sandy Coombs +1 781 609 6377
For Media: Katie Joyce +1 781 249 8927
Original: Alkermes plc Announces CEO Succession Plan
Hot Features
プレミアム
登録してリアルタイムのアラート、カスタムポートフォリオ、市場の動きを入手してください。
iHub News
2月前
JRoon71
3年前
ValueInvestor15
9年前
balamidas
10年前
conix
10年前
TheFinalCD
10年前
stocktrademan
10年前
surf1944
12年前
メールアドレスで登録
