FDA’s Office of Drug Evaluation III Denies Agile Therapeutics, Inc.’s Initial Formal Dispute Resolution Request
July 24 2018 - 4:10PM
Company Plans to Appeal to the FDA’s Office of
New Drugs
Agile Therapeutics, Inc., (Nasdaq:AGRX) (the “Company”), a women’s
healthcare company, today announced that the Office Director of the
FDA’s Office of Drug Evaluation III (ODEIII) has affirmed the
position of the Division of Bone, Reproductive and Urologic
Products (DBRUP) and denied the Company’s appeal of the December
21, 2017 Complete Response Letter in relation to the New Drug
Application (NDA) for Twirla®. The Company had appealed the
decision by DBRUP that concerns surrounding the in vivo adhesion
properties of Twirla prevent its approval and cannot be addressed
through the Company’s proposed patient compliance programs.
The Company intends to appeal the ODEIII decision to the Office of
New Drugs.
Agile initiated formal dispute resolution with the FDA’s ODEIII
on June 6, 2018 to appeal the December 21, 2017 CRL for
Twirla. The appeal was submitted in accordance with the
formal dispute resolution process following an end-of-review
meeting in April 2018 in which the FDA provided the Company with a
more complete understanding of its assessment of the Twirla NDA and
the adhesion data for Twirla contained therein. The formal
dispute resolution process exists to encourage open, prompt
discussion of scientific and procedural disputes that arise during
drug development, new drug review, and post-marketing oversight
processes of the FDA. Through this process the Company has
the ability to escalate its appeal to additional levels of FDA
management.
“We are clearly disappointed in the Office Director’s decision
to deny our formal dispute resolution request,” said Al Altomari,
Chairman and Chief Executive Officer, Agile Therapeutics. “We
disagree with the Office Director’s conclusions and continue to
believe that our Phase 3 SECURE trial yielded in vivo adhesion data
that are adequate for Twirla’s approval, and more importantly, that
did not impact clinical outcomes. We look forward to
discussing our positions with a representative from the Office of
New Drugs as we continue to pursue formal dispute resolution.”
About Twirla® (AG200-15)Twirla
(levonorgestrel/ethinyl estradiol transdermal system) or AG200-15
is an investigational low-dose, once-weekly contraceptive patch.
AG200-15 is a combined hormonal contraceptive (CHC) patch that
contains the active ingredients ethinyl estradiol (EE), a type of
estrogen and levonorgestrel (LNG), a type of progestin. Twirla is
designed to be applied once weekly for three weeks, followed by a
week without a patch. Agile received a complete response
letter (CRL) from the FDA on December 21, 2017 relating to the New
Drug Application (NDA) for Twirla. In the CRL, the FDA
informed the Company that the product could not be approved in its
present form due to deficiencies related to quality adhesion test
methods, observations identified during the pre-approval inspection
of the manufacturing facility for Twirla, and because of questions
the FDA had on the in vivo adhesion properties of Twirla and their
potential relationship to the Company’s Phase 3 clinical trial
results. As announced on May 18, 2018, Agile met with the FDA
during a Type A meeting on April 16, 2018 to discuss the CRL and
received the official end of review (EOR) minutes on May 15, 2018.
The Company initiated formal dispute resolution with the FDA
on June 6, 2018 in response to the FDA’s position on Twirla’s in
vivo adhesion properties communicated in the EOR minutes. The
Company believes the FDA provided guidance on a path forward for
addressing the manufacturing issues related to Twirla.
About Agile Therapeutics, Inc. Agile
Therapeutics is a forward-thinking women's healthcare company
dedicated to fulfilling the unmet health needs of today's women.
Our product candidates are designed to provide women with
contraceptive options that offer freedom from taking a daily pill,
without committing to a longer-acting method. Our lead product
candidate, Twirla® (levonorgestrel/ethinyl estradiol transdermal
system) or AG200-15, is an investigational low-dose, non-daily,
prescription contraceptive. Twirla is based on our proprietary
transdermal patch technology, called Skinfusion®, which is designed
to allow drug delivery through the skin. For more
information, please visit the company website at
www.agiletherapeutics.com. The Company may occasionally disseminate
material, nonpublic information on the Company’s website.
Follow Agile on Linked In and Twitter: @AgileTher.
Forward-Looking StatementCertain information
contained in this press release includes "forward-looking
statements" related to our regulatory submissions and projected
cash position. We may, in some cases use terms such as "predicts,"
"believes," "potential," "continue," "anticipates," "estimates,"
"expects," "plans," "intends," "may," "could," “might," “likely,”
"will," "should" or other words that convey uncertainty of the
future events or outcomes to identify these forward-looking
statements. Our forward-looking statements are based on current
beliefs and expectations of our management team that involve risks,
potential changes in circumstances, assumptions, and uncertainties,
including statements regarding our ability to succeed in formal
dispute resolution with the FDA, which can be lengthy and expensive
and the success of which is not guaranteed and our belief that
Twirla’s adhesion profile is adequate for approval and a
reformulation of Twirla is not necessary. Any or all of the
forward-looking statements may turn out to be wrong or be affected
by inaccurate assumptions we might make or by known or unknown
risks and uncertainties. These forward looking statements are
subject to risks and uncertainties including risks related to our
ability to either succeed in our formal dispute resolution with the
FDA, or, if we are unsuccessful, our ability to develop a
reformulation that will address the FDA’s concerns, if we are
required to reformulate Twirla, our ability to successfully
complete an additional adhesion study and bioequivalence study, the
potential that we may be required to conduct an additional Phase 3
trial, the likelihood that we will require additional
correspondence with the FDA prior to the resubmission of our NDA,
our ability to resubmit and the timing of our resubmission of the
NDA for Twirla, FDA acceptance and approval of the resubmitted NDA,
or whether other issues will arise that will negatively impact
acceptance, review, and approval of Twirla by the FDA, our ability
to address the deficiencies identified by the FDA in the CRL issued
in December 2017 and in the Type A meeting minutes issued in May
2018, and unforeseen market factors or events in our clinical and
manufacturing development plans and the other risks set forth our
filings with the U.S. Securities and Exchange Commission, including
our Annual Report on Form 10-K and our Quarterly Reports on Form
10-Q. For all these reasons, actual results and developments
could be materially different from those expressed in or implied by
our forward-looking statements. You are cautioned not to place
undue reliance on these forward-looking statements, which are made
only as of the date of this press release. We undertake no
obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
SOURCE: Agile Therapeutics, Inc.
Contact:Investor Relations Agile
Therapeutics609-683-1880
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