ARS Pharmaceuticals Announces Availability of Briefing Documents for FDA Advisory Committee Meeting on neffy® for the Treatment of Type I Allergic Reactions Including Anaphylaxis
2023年5月9日 - 10:10PM
ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), a biopharmaceutical
company dedicated to empowering at-risk patients and caregivers to
better protect themselves from severe allergic reactions that could
lead to anaphylaxis, today announced that the U.S. Food and Drug
Administration (FDA) posted briefing documents for the Pulmonology,
Allergy-Drugs Advisory Committee (PADAC) meeting to review the new
drug application (NDA) for
neffy®.
neffy has the potential to be the first,
non-injectable epinephrine nasal spray medicine for the treatment
of patients with allergic reactions (type 1), including
anaphylaxis.
The advisory committee meeting is scheduled to begin at 9:00 AM
ET on May 11, 2023. Briefing materials, including FDA’s addendum to
the documents, and webcast information for the meeting can be
accessed at
https://www.fda.gov/advisory-committees/advisory-committee-calendar/may-11-2023-pulmonary-allergy-drugs-advisory-committee-meeting-announcement-05112023#event-materials.
The Company is not responsible for the content of, nor the
statements made in, the briefing materials that were prepared by
the FDA.
“We are confident in the robust data package with
neffy and believe our submission contains the
information FDA indicated would be appropriate to support a
potential approval of the first-ever non-injectable epinephrine
spray,” said Richard Lowenthal, Co-Founder, President and Chief
Executive Officer at ARS Pharma. “We look forward to discussing
this information with the PADAC members and presenting the details
of our clinical findings across multiple registrational studies
later this week.”
ARS’s NDA submission was based on data from four primary
registrational studies showing that 2.0 mg intranasal dose of
neffy met all clinical endpoints recommended by
FDA and that its pharmacokinetics were within the range of approved
epinephrine injection products. These data included studies in
adults, with self-administration and caregiver administration, as
well as in children with Type I allergies ≥30 kg (66 lbs). In
addition, neffy has been well-tolerated to date
with more than 600 individuals in clinical trials receiving at
least one dose, and many with repeat administration. Adverse events
in neffy clinical trials were generally mild in
nature without any meaningful nasal irritation or pain, and no
serious adverse events were reported in any clinical study.
The Company’s NDA submission for neffy was
accepted for review by the FDA with a Prescription Drug User Fee
Act (PDUFA) target action date anticipated in mid-2023.
About Type I Allergic Reactions including
AnaphylaxisType I severe allergic reactions are serious
and potentially life-threatening events that can occur within
minutes of exposure to an allergen and require immediate treatment
with epinephrine, the only FDA-approved medication for these
reactions. While epinephrine autoinjectors have been shown to be
highly effective, there are well published limitations that result
in many patients and caregivers delaying or not administering
treatment in an emergency situation. These limitations include fear
of the needle, lack of portability, needle-related safety concerns,
lack of reliability, and complexity of the devices. There are
approximately 25 to 40 million people in the United States who
experience Type I severe allergic reactions. Of those, only 3.3
million currently have an active epinephrine autoinjector
prescription, and of those, only half consistently carry their
prescribed autoinjector. Even if patients or caregivers carry an
autoinjector, more than half either delay or do not administer the
device when needed in an emergency.
About ARS Pharmaceuticals, Inc.ARS is a
biopharmaceutical company dedicated to empowering at-risk patients
and caregivers to better protect themselves from severe allergic
reactions that could lead to anaphylaxis. The Company is
developing neffy® (also
referred to as ARS-1), an intranasal epinephrine product in
clinical development for patients and their caregivers with Type I
allergic reactions including food, medications and insect bites
that could lead to life-threatening anaphylaxis. For more
information, visit www.ars-pharma.com.
Forward-Looking StatementsStatements in this
press release that are not purely historical in nature are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements include,
but are not limited to, the potential of neffy to
be the first, non-injectable epinephrine nasal spray medicine for
the treatment of patients with allergic reactions (type 1),
including anaphylaxis; ARS’s belief that its NDA submission for
neffy will be sufficient to support a potential
approval of neffy; and other statements that are
not historical fact. Because such statements are subject to risks
and uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Words such
as “anticipate,” “plans,” “expects,” “will,” “potential” and
similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon ARS’s
current expectations and involve assumptions that may never
materialize or may prove to be incorrect. Actual results and the
timing of events could differ materially from those anticipated in
such forward-looking statements as a result of various risks and
uncertainties, which include, without
limitation, the PADAC or the FDA may not view the data
used to support the NDA submission to be sufficient to recommend
the approval of, or to approve, respectively,
neffy; and the PADAC meeting or the PDUFA
target action date may be delayed due to various factors outside
ARS’s control. Additional risks and uncertainties that could cause
actual outcomes and results to differ materially from those
contemplated by the forward-looking statements are included under
the caption “Risk Factors” in ARS’s Annual Report on Form 10-K for
the year ended December 31, 2022, as filed with the Securities
and Exchange Commission (SEC) and available at www.sec.gov. This
and other documents ARS files with the SEC can also be accessed on
ARS’s web page at ir.ars-pharma.com by clicking on the link
“Financials & Filings.”
The forward-looking statements included in this press release
are made only as of the date hereof. ARS assumes no obligation and
does not intend to update these forward-looking statements, except
as required by law.
Media Contact:Arielle Bernstein PinsofFINN
Partnersarielle.pinsof@finnpartners.com
Investor Contacts:Monique AllaireTHRUST
Strategic Communicationsmonique@thrustsc.com
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