- PRIALT® (ziconotide) is the only FDA-approved, non-opioid
intrathecal infusion treatment option for patients suffering from
severe chronic pain for whom intrathecal therapy is warranted, and
who are intolerant of or refractory to other treatments.
TerSera Therapeutics LLC announced today that the 2024
Polyanalgesic Consensus Conference (PACC) guidelines reinforce the
role of non-opiate PRIALT in treating severe chronic pain. The 2024
PACC guidelines build upon prior iterations. This includes the 2016
PACC guidelines which recommend PRIALT as a first line option for
neuropathic (chronic pain that occur when a health condition
affects the nerves that send sensations to the brain) and
nociceptive pain (pain caused by damage to body tissue).1 The
updated PACC Guidelines were published in the journal of
Neuromodulation on May 16, 2024.2
As noted in the guidelines, “proper individualized dosing is
paramount for success with ziconotide.” The updated 2024 PACC
guidelines discuss several crucial parameters for starting a
patient successfully on PRIALT. Please refer to the full 2024 PACC
Guidelines for additional information.2
“The updated 2024 PACC guidelines provide clinicians with
recommendations on how to manage PRIALT therapy for patients with
severe, chronic pain,” said Gladstone C. McDowell II, MD. Dr.
McDowell is the founder and former Medical Director of Integrated
Pain Solutions in Columbus, Ohio and an author of the PACC
guidelines. “In addition, it is beneficial to have an effective
non-opioid analgesic option for this patient population. I
appreciate having the ability to mitigate the potential risk of
dependence and addiction for patients by using PRIALT.”
Nancy Martin, MD, PharmD, Chief Medical Officer at TerSera,
commented, “The PACC guidelines expert panel has continued to
support PRIALT as an option for patients with severe, chronic pain
who are refractory to other treatments."
The International Neuromodulation Society (INS) commissioned a
panel of distinguished clinical experts, and a series of
Polyanalgesic Consensus Conferences produced the first guidelines
after the inaugural meeting in 1999.2 The authors of the PACC
guidelines consist of an international, multidisciplinary team of
experts in the intrathecal drug delivery.1-2
PRIALT approved by the U.S. Food and Drug Administration (FDA)
in 2004, is used to manage severe chronic pain in adults when other
treatments do not work, stop working or cannot be tolerated. PRIALT
is placed directly into the spinal fluid (termed “intrathecal” use)
by a qualified physician who determines that the patient is
appropriate for this procedure. PRIALT is not an opioid and is not
a controlled, scheduled drug, meaning that the drug does not show
the potential for dependence and subsequent abuse.4
According to the Centers for Disease Control and Prevention
(CDC), it is estimated that nearly 17 million Americans suffer from
severe chronic pain of some kind.3 Chronic pain conditions may be
the result of more than one cause—damage to body tissues
(nociceptive), damage to the nervous system (neuropathic), or a mix
of the two.1-2 Severe chronic pain patients are treated in a
variety of ways, including use of oral opioids, transdermal
opioids, physical therapy, injection therapy, spinal cord
stimulation, spinal surgery, and more. When these methods do not
adequately manage the individual’s pain, many doctors prescribe an
intrathecal infusion treatment in which a pump is surgically
implanted in the abdomen to deliver pain medication directly to the
spinal cord to inhibit pain signals. In addition to PRIALT, only
morphine is FDA-approved as an intrathecal (IT) infusion treatment
for severe chronic pain.
ABOUT TERSERA THERAPEUTICS
TerSera Therapeutics is a biopharmaceutical company with a focus
in oncology, acute care, and non-opioid pain management. Founded in
2016, TerSera is building new cornerstones of care through its
portfolio of unique therapeutics, amplifying their ability to
deliver meaningful outcomes for patients. For more information
about TerSera Therapeutics, please visit tersera.com.
ABOUT PRIALT4
PRIALT intrathecal solution is an N-type calcium channel
antagonist used to treat severe chronic pain in patient’s
refractory to other treatments. PRIALT was first approved in 2004;
PRIALT is available as a 1- or 5-mL vial of 100 mcg/mL solution or
a 20 mL vial of 25 mcg/mL solution.
INDICATION
PRIALT is a prescription medicine used to treat severe chronic
pain in adults who cannot take other treatments or when other
treatments do not work, stop working, or cause bothersome side
effects. PRIALT can only be delivered by or under the direction of
a doctor who injects the medicine into your spinal fluid through a
special device (a procedure called intrathecal infusion) and should
only be used in patients who are appropriate for the procedure.
IMPORTANT SAFETY INFORMATION
PRIALT may cause serious side effects
including psychiatric (mental) symptoms and problems thinking
(confusion, memory problems, speech difficulties). The doctor
should be called immediately if, while taking PRIALT, you are
confused or disoriented, are less alert, see or hear things that
are not real (hallucinations), have changes in mood or
consciousness.
Your doctor may stop your treatment with
PRIALT, give you other medicines, or require you to be hospitalized
if you experience any of these symptoms.
You should not be given PRIALT if you:
- are allergic to PRIALT or any of its ingredients
- have a condition or are receiving a treatment that would cause
an injection in your spinal fluid to be unsafe
- have or had a mental illness called psychosis (a loss of
contact with reality), usually including delusions (false beliefs
about what is taking place or who one is) or hallucinations (seeing
or hearing things that are not real)
PRIALT may cause or worsen depression, which increases the risk
of suicide. People 65 years of age and older have a higher risk for
confusion with PRIALT. Taking certain other medicines along with
PRIALT may raise the risk of having problems with thinking or
alertness. Tell your doctor about all the medicines you are
taking.
Meningitis (inflammation of the protective membranes covering
the brain and spinal cord) or other infections can happen if the
infusion device becomes contaminated. Tell your doctor right away
if you have fever, headache, stiff neck, changes in mental status
(feeling tired, confused, disoriented), nausea, vomiting, and/or
seizures as these may be symptoms of developing meningitis.
PRIALT may cause unconsciousness or reduced mental alertness.
Avoid activities where you need to be alert, awake, and have full
control of your body (activities like operating machinery or
driving a car) during treatment with PRIALT.
Tell the doctor if you experience new or worsening muscle pain,
soreness, weakness or if your urine is dark in color as this could
be a sign of rare but serious muscle side effects.
You should also tell the doctor if you are pregnant, plan to
become pregnant or if you are breastfeeding.
The most common side effects of PRIALT include dizziness,
nausea, confusion, and uncontrolled eye movements. These are not
all the possible side effects of PRIALT. Talk to your doctor about
any side affects you may be experiencing.
To report suspected adverse reactions, contact the FDA at
1-800-FDA-1088 or www.FDA.gov/medwatch. You may also contact
TerSera Therapeutics at 1-844-334- 4035 or
medicalinformation@tersera.com.
Please see Important Safety Information above and full
Prescribing Information, including BOXED Warning.
References
1.
Deer T.R., Pope J.E., Hayek S., Lamer
T.J., Veizi I.E., Erdek M., Wallace M.S., Grider J.S., Levy R.M.,
Prager J., Rosen S.M., Saulino M., Yaksh T.L., De Andres J.A.,
Abejon Gonzalez D.,Vesper J., Schu S.,Simpson B.,Mekhail N. 2017.
The Polyanalgesic Consensus Conference (PACC): Recommendations for
Intrathecal Drug Delivery: Guidance for Improving Safety and
Mitigating Risks. Neuromodulation 2017; E-pub ahead of print.
DOI:10.1111/ner.12579
2.
Deer T.R., Hayek S.M., Grider J.S.,
Hagedorn J.M., McDowell G.C., Kim P., Dupoiron D., Goel V., Duarte
R., Pilitsis J.G., Leong M.S., De Andrés J., Perruchoud C.,
Sukumaran H., Abd-Elsayed A., Saulino M., Patin D., Poree L.R.,
Strand N., Gritsenko K., Osborn J.A., Dones I., Bux A., Shah J.M.,
Lindsey B.L., Shaw E., Yaksh T.L., Levy R.M. 2024. The
Polyanalgesic Consensus Conference (PACC)®: Intrathecal Drug
Delivery Guidance on Safety and Therapy Optimization When Treating
Chronic Non-cancer Pain. Neuromodulation 2024; -:1–33.
3.
Rikard, S. M., Strahan, A. E., Schmit, K.
M., & Guy Jr., G. P. (2023). Chronic Pain Among Adults — United
States, 2019–2021. MMWR Morbidity and Mortality Weekly Report,
72(15), 433–438.
4.
PRIALT® (ziconotide). Prescribing
information. TerSera Therapeutics LLC.
PRIALT is a registered trademark of TerSera Therapeutics LLC
©2024TerSera Therapeutics LLC. All rights reserved. PRI-P-1170v2
(07/2024)
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Mark Leonard mleonard@tersera.com 847-651-9682