ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical
company dedicated to empowering at-risk patients and caregivers to
better protect patients from severe allergic reactions that could
lead to anaphylaxis, today announced that the U.S. Food and Drug
Administration (FDA) issued a Complete Response Letter (CRL)
regarding its New Drug Application (NDA) for
neffy® (epinephrine nasal spray) in the treatment
of Allergic Reactions (Type I), including anaphylaxis for adults
and children ≥30 kg. ARS Pharma plans to submit a Formal Dispute
Resolution Request (FDRR) to appeal the issuance of this CRL.
In the letter, the FDA requested completion of a
pharmacokinetic/pharmacodynamic study assessing repeat doses of
neffy compared to repeat doses of an epinephrine
injection product under allergen-induced allergic rhinitis
conditions to support approval. This request comes after the
recommendation of the FDA Advisory Committee (PADAC) in May 2023 to
approve neffy without the need for additional
studies to demonstrate its efficacy or safety. Further, FDA and ARS
Pharma previously aligned in August 2023 on final physician’s
labeling and a post-marketing requirement to conduct this study as
informative for labeling.
The PADAC meeting was held on May 11, 2023, and concluded a
favorable benefit-risk profile of neffy, with a
16:6 vote in favor for adults and 17:5 vote in favor for children
(≥30 kg) for the treatment of patients with allergic reactions
(Type I), including anaphylaxis. In that session, no member of the
Committee raised specific concerns about the result of the
completed study in people with allergen-induced acute rhinitis with
single-dose neffy, which showed enhanced
absorption during the time period when a clinical response would be
expected.
“We are very surprised by this action and the late requirement
at this time to change the repeat-dose study from a post-marketing
requirement, which we had previously aligned on with FDA, to a
pre-approval requirement, particularly given the positive Advisory
Committee vote. In fact, multiple Committee members highlighted the
favorable profile of neffy in our completed
single-dose nasal allergy challenge study and that any decline in
exposure 20 minutes after dosing, after the expected response
period, is of no concern,” said Richard Lowenthal, Co-founder,
President and CEO of ARS Pharma. “We stand by the totality of the
neffy data package generated in a comprehensive
registration program that was aligned upon with FDA and believe
strongly in the value neffy can provide for
patients, families and caregivers living daily with severe allergic
reactions.”
Mr. Lowenthal continued, “If approved, neffy
would represent the first-ever needle-free nasal spray epinephrine
treatment for people with severe allergic reactions that has been
shown to be more easily carried and administered, without anxiety
or hesitation, which is critical to stopping disease progression.
We have heard a tremendous outpouring of support from the patient,
advocacy, and physician communities, who have a critical need for a
needle-free epinephrine treatment. We are deeply disappointed that
this action further delays the availability of
neffy for the millions of people who are at risk
of a potentially life-threatening severe allergic reaction.
Patients and caregivers are waiting for neffy, and
we aim to complete the newly requested trial as quickly as possible
to meet the needs of patients.”
As ARS Pharma previously agreed with FDA to conduct a
repeat-dose study under allergen-induced allergic rhinitis
conditions as a post-marketing commitment, ARS Pharma anticipates a
resubmission to the FDA in the first half of 2024, positioning ARS
Pharma for an anticipated FDA action date in the second half of
2024.
ARS Pharma expects to have anticipated cash, cash equivalents
and short-term investments on hand of approximately $195 million at
the time of the anticipated launch of neffy, if
approved in the second half of 2024.
The CRL requested additional information on nitrosamine
impurities to be tested for based on new draft guidance issued
after the neffy NDA submission. ARS Pharma does
not believe the additional testing would be a rate-limiting step
for its resubmission to the FDA.
A marketing authorization application for neffy
is also under review by the European Medicines Agency with a
Committee for Medicinal Products for Human Use opinion expected by
year end 2023. Submissions to other regulatory authorities in
additional countries are planned for 2024.
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 40 million people in the United States who experience
Type I severe allergic reactions due to food, venom or insect
stings. 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 Pharma is a
biopharmaceutical company dedicated to empowering at-risk patients
and caregivers to better protect patients 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 ARS Pharma’s ability to complete the newly
required trial and provide the additional information requested by
the FDA in the CRL on the timing anticipated, or at all; the
potential approval of neffy; the expected
timing for the Committee for Medicinal Products for Human Use
opinion with respect to the marketing authorization application for
neffy; the expected submissions
of neffy to other regulatory authorities in
additional countries and the timing thereof; ARS Pharma’s cash,
cash equivalents and short-term investments on hand upon any future
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
Pharma’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 ability to successful complete
the newly requested trial on the timeframe anticipated at all, as a
result of challenges inherent to enrolling, conducting and
completing clinical trials; the results of the new clinical trial
may not support the approval of neffy; results
from clinical trials may not be indicative of results that may be
observed in the future; potential safety and other complications
from neffy; the labelling
for neffy, if approved; the scope, progress
and expansion of developing and
commercializing neffy; the size and growth of
the market therefor and the rate and degree of market acceptance
thereof vis-à-vis intramuscular injectable products; ARS Pharma’s
ability to protect its intellectual property position; and the
impact of government laws and regulations. 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
Pharma’s Quarterly Report on Form 10-Q for the quarter
ended June 30, 2023, filed with the Securities and
Exchange Commission on August 10, 2023. This document can also
be accessed on ARS Pharma’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 Pharma assumes no
obligation and does not intend to update these forward-looking
statements, except as required by law.
ARS Pharma Investor Contact:Justin ChakmaARS
Pharmaceuticalsjustinc@ars-pharma.com
Monique AllaireTHRUST Strategic
Communicationsmonique@thrustsc.com
ARS Pharma Media Contact:Laura O'NeillFINN
Partnerslaura.oneill@finnpartners.com
ARS Pharmaceuticals (NASDAQ:SPRY)
Gráfico Histórico do Ativo
De Mai 2024 até Jun 2024
ARS Pharmaceuticals (NASDAQ:SPRY)
Gráfico Histórico do Ativo
De Jun 2023 até Jun 2024