FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for neffy® (Intranasal (IN) Epinephrine) for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis
12 May 2023 - 9:01AM
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’s (FDA) Pulmonary-Allergy Drug Advisory Committee
(PADAC) voted 16:6 in favor for adults, and 17:5 in favor for
children (<18 years of age and ≥30 kg), that available data
support a favorable benefit-risk assessment for
neffy in the treatment of severe allergic reaction
(Type 1), including anaphylaxis,for adults and children who weigh
more than 30kg.
“We’d like to thank PADAC members for their robust scientific
discussions and clinical perspectives. The committee’s thoughtful
review of the data, and support of the potential for
neffy to address significant unmet needs of the
severe allergy community, if approved, is highly encouraging,” said
Richard Lowenthal, Co-founder, President and Chief Executive
Officer, ARS Pharmaceuticals. “We believe our clinical data from
more than 600 individuals demonstrate neffy’s
absorption-enhancing nasal spray technology is comparable to
injectable products in delivering potentially lifesaving
epinephrine, but with unique advantages of being small, needle-free
and conveniently sized. We are committed to making it easier for
patients and caregivers to carry and administer epinephrine without
the anxiety and hesitation associated with using a needle-based
device. We were moved by the outpouring of support for
neffy ahead of and throughout this meeting, and we
are especially grateful to those individuals who shared their
personal experiences, illustrating the positive impact
neffy may create for millions of individuals and
families in the future.”
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 PADAC decision was based on a review of comprehensive data
from clinical studies developed in agreement with the FDA, which
support a positive risk-benefit profile for intranasal (IN)
epinephrine safety and effectiveness, compared to epinephrine
injection. The studies demonstrated and the Committee’s discussion
supported that neffy shows:
- Comparable pharmacokinetic (PK) data (epinephrine levels in the
blood) vs. intramuscular injection including the first 10 to 20
minutes when clinical response is observed
- Comparable or greater pharmacodynamic (PD)response (systolic
blood pressure and heart rate) vs. intramuscular injection that is
observed even at 1 minute after dosing of
neffy
- Effective IN delivery of systemic epinephrine and PD response
even with nasal congestion or runny nose (e.g., during allergic
rhinitis or upper respiratory tract infection)
- Comparable safety to injection that is generally mild in nature
without any meaningful nasal irritation or pain, without
needle-related risks
Additionally, neffy’s sprayer device has been
approved by FDA for drug delivery for six other products in the
United States, many of which are intended for emergency use.
“Patients need options – with different administration methods –
to facilitate actual epinephrine use in an emergency event,” said
Carlos Camargo, MD, DrPH, Professor of Emergency Medicine, Harvard
Medical School. “The data presented today show robust evidence of
comparable pharmacokinetic (PK) and pharmacodynamic (PD) responses
for neffy compared to injection, even in patients
with rhinitis or nasal congestion. The effects of epinephrine on
blood pressure and heart rate are surrogates for efficacy and are
important in determining if someone is responding to treatment.
With neffy, blood pressure and heart rate are
comparable to EpiPen with a single dose – and with a second dose of
neffy, increases in systolic blood pressure were
statistically higher, even better than revealed in the available
data from EpiPen, which is crucial for patients requiring a second
dose for a severe allergic reaction.”
While PADAC recommendations are non-binding, the FDA will
consider this outcome in its review of the pending New Drug
Application (NDA) for neffy. The FDA has assigned
a Prescription Drug User Fee Act (PDUFA) target action date
anticipated mid-2023. If approved, neffy would be
the first non-injectable treatment available to patients with
allergic reactions (Type 1) including anaphylaxis.
“Millions of people have been waiting decades for a new delivery
method of epinephrine, and we are grateful to the community for
sharing their personal experiences and illustrating the potential
neffy has in changing lives. We continue
discussions with private payers, pharmacy benefit managers, and
retail pharmacies to ensure that if neffy receives
FDA approval, we are ready to make this important new treatment
modality widely available for those who need it,” Mr. Lowenthal
added.
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 anticipated timing for regulatory
review decisions on neffy and the potential
approval of neffy; the implications of the PADAC
decision; ARS being ready to make neffy, if
approved, widely available for those who need it; the estimated
addressable patient population for 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,” “believe,”
“plan,” “will,” “potential,” “may” 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 ability to
obtain and maintain regulatory approval for neffy;
the PADAC decision should not be relied on as an indication that
neffy will ultimately be approved; the FDA is not
bound by the PADAC decision or any of its recommendations and there
are a number of instances where the FDA has voted against the
recommendations of advisory committees; the PDUFA target action
date may be delayed due to various factors outside ARS’s control;
the FDA’s prior approval of neffy’s sprayer device
for drug delivery for six other products should not be relied on as
an indication that FDA will approve the sprayer device for the
administration of neffy; the labelling for
neffy, if approved; the scope, progress and
expansion of developing and commercializing neffy,
if approved, including the ability to enter into distribution
arrangements and obtain favorable reimbursement; the size and
growth of the market therefor and the rate and degree of market
acceptance thereof vis-à-vis intramuscular injectable products;
ARS’s ability to protect its intellectual property position; the
impact of government laws and regulations; and ARS’s ability to
execute its plans and strategies. 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 the
company’s Annual Report on Form 10-K for the year ended December
31, 2022, filed with the Securities and Exchange Commission (“SEC”)
on March 23, 2023. 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.
ARS Investor Contact:Justin ChakmaARS
Pharmaceuticalsjustinc@ars-pharma.com
ARS Media Contact:Laura O'NeillFINN
Partnerslaura.oneill@finnpartners.com
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