Adamis Provides Regulatory Update on Sublingual Tadalafil
26 Febrero 2019 - 5:54PM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced
that it has received a Refusal to File letter from the United
States Food and Drug Administration (FDA) regarding its New Drug
Application (NDA) for its sublingual tadalafil product. As
previously announced, on December 28th, 2018, Adamis submitted an
NDA for fast-disintegrating sublingual tadalafil (APC-8000) with
the FDA for the treatment of erectile dysfunction (ED).
Upon its preliminary review, the FDA determined that the
submitted NDA was not sufficiently complete to permit a substantive
review. The FDA requested that Adamis supplement and include in a
resubmitted NDA (i) longer real-time (versus accelerated) stability
data and (ii) additional dissolution data for both the clinical and
registration batches. Adamis may seek immediate guidance from the
FDA, including requesting a Type A meeting, to discuss the letter
with the agency and seek additional guidance concerning
information, data and specific deliverables that the agency would
require for a resubmitted NDA to be deemed complete.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “We
are obviously very disappointed with this development and are
evaluating the letter and what the FDA has requested. We intend to
work closely with the FDA to try to clearly map the path
forward.”
Tadalafil is a drug used for treating erectile dysfunction (ED),
pulmonary hypertension and benign prostatic hyperplasia
(BPH). Tadalafil is in a class of drugs called
phosphodiesterase-5 (PDE5) inhibitors which includes, among others,
sildenafil and vardenafil. Tadalafil is the drug in Lilly’s
Cialis®, sildenafil is the drug in Viagra® (Pfizer) and vardenafil
is the drug in Levitra® (GlaxoSmithKline). All three drugs of
these oral tablets are FDA approved and clinically indicated for
the treatment of ED.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty
biopharmaceutical company primarily focused on developing and
commercializing products in various therapeutic areas, including
respiratory disease and allergy. The company’s Symjepi
(epinephrine) Injection 0.3mg and Symjepi (epinephrine) Injection
0.15 mg products were approved for use in the emergency treatment
of acute allergic reactions, including anaphylaxis. Adamis
previously announced a distribution and commercialization agreement
with Sandoz, a division of Novartis Group, to market Symjepi in the
U.S. Adamis is developing additional products, including a
sublingual tadalafil product candidate for the treatment of
erectile dysfunction, a naloxone injection product candidate for
the treatment of opioid overdose, and a metered dose inhaler and
dry powder inhaler product candidates for the treatment of asthma
and COPD. The company’s subsidiary, U.S. Compounding, Inc.,
compounds sterile prescription drugs, and certain nonsterile drugs
for human and veterinary use, to patients, physician clinics,
hospitals, surgery centers and other clients throughout most of the
United States.
Adamis Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. These statements relate to future events, future
results of operations, or future risks and uncertainties,
including, but not limited to the following matters: the
company’s intention to request a Type A meeting with the FDA to
discuss the refusal to file letter and the timing, occurrence and
outcome of any such meeting with the FDA; what additional
supporting data, information, studies or trials will be required or
sufficient before the FDA will accept an NDA filing for the
company’s tadalafil product candidate; whether any such required
clinical trials or studies will be successful; whether any
subsequent studies or data will demonstrate clinical superiority to
existing products; whether any future clinical trials for the
tadalafil product candidate will be completed on time or at all;
potential changes in cost, scope and duration of the clinical
development program relating to the tadalafil product candidate;
whether the company will resubmit its New Drug Application for its
tadalafil product candidate; risks that the tadalafil NDA is not
accepted for filing by the FDA; the timing of any future FDA review
and acceptance of a resubmitted NDA; the timing or ultimate outcome
of the FDA’s review of the company’s NDA relating to its tadalafil
tablet product candidate; if approved, whether the company’s
tadalafil product candidate will be commercialized successfully;
the company’s ability to advance its development-stage product
candidates, including the tadalafil product candidate; and other
statements concerning our future operations and activities.
Such forward-looking statements include those that express plans,
anticipation, intent, contingencies, goals, targets or future
development and/or otherwise are not statements of historical
fact. These statements are only predictions, are not
guarantees, involve known and unknown risks, uncertainties and
other factors, and concern matters that could subsequently differ
materially from those described in this press release, which may
cause Adamis' actual results to be materially different from those
contemplated by these forward-looking statements. There is no
assurance that the FDA will accept our NDA or a
resubmitted NDA relating to our tadalafil tablet product candidate
or that other matters or events relating to the submission and
regulatory review process under Section 505(b)(2) of the Food, Drug
& Cosmetic Act will not differ from our expectations or result
in delays in the regulatory approval process. In addition,
forward-looking statements concerning our anticipated future
activities assume that we are able to obtain sufficient funding to
support such activities and continue our operations and planned
activities. As discussed in our filings with
the Securities and Exchange Commission, we may require
additional funding, and there are no assurances that such funding
will be available if required. We cannot assess the impact of
each factor on our business or the extent to which any factor, or
combination of factors, may cause actual results to differ
materially from those contained in any forward-looking
statements. You should not place undue reliance on any
forward-looking statements. Further, any forward-looking
statement speaks only as of the date on which it is made, and
except as may be required by applicable law, we undertake no
obligation to update or release publicly the results of any
revisions to these forward-looking statements or to reflect events
or circumstances arising after the date of this press
release. Certain of these risks, and additional risks,
uncertainties, and other factors are described in greater detail in
our filings from time to time with the SEC, including our
annual report on Form 10-K for the year ended December 31,
2017, and our subsequent filings with the SEC, which Adamis
strongly urges you to read and consider, all of which are available
free of charge on the SEC's web site
at http://www.sec.gov.
Contacts: Mark Flather Senior Director,
Investor Relations& Corporate Communications Adamis
Pharmaceuticals Corporation (858)
412-7951mflather@adamispharma.com
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