Agile Therapeutics, Inc. Receives a Complete Response Letter from the FDA for Twirla® (AG200-15) for the Prevention of Pregn...
December 22 2017 - 7:30AM
Agile Therapeutics, Inc., (NASDAQ:AGRX), a women’s healthcare
company, today announced that the U.S. Food and Drug Administration
(FDA) issued a complete response letter (CRL) in response to the
New Drug Application (NDA) resubmission for the Company’s
investigational non-daily, low dose combination hormonal
contraceptive patch, Twirla (AG200-15). The resubmission of the
NDA, which is seeking approval for Twirla was accepted for review
earlier this year. The Prescription Drug User Fee Act (PDUFA)
goal date was December 26, 2017. The CRL states that the FDA
has determined that it cannot approve the NDA in its present form.
The CRL identifies deficiencies relating to quality adhesion
test methods. The CRL also noted that observations identified
during an inspection of a facility of the Company’s third-party
manufacturer, Corium International Inc., (Corium), for the Twirla
NDA must be resolved. Lastly, the CRL questions the in vivo
adhesion properties of Twirla and their potential relationship to
the SECURE phase 3 clinical trial results. The CRL contains
recommendations for developing manufacturing in-process tests for
ensuring the quality and in vivo adhesion of the commercial scale
product as well as the finished drug specifications and release
test method for adhesion. The CRL also recommends that the
Company assess the in vivo adhesion properties demonstrated in the
SECURE clinical trial. Finally, the CRL recommends that the Company
address the implications of clinical trial subject patch compliance
and the withdrawal and dropout rates. The CRL does not
identify any specific issues relating to the safety of Twirla.
During the review cycle, the Company submitted an amendment to
the NDA in response to an information request from the FDA on the
issues related to quality adhesion test methods cited in the
CRL. In addition, Corium also provided the FDA responses
addressing each of the observations made during the FDA’s facility
inspection on November 20, 2017 and December 1, 2017. The CRL
acknowledges receipt of the Company’s NDA amendment submitted on
December 1, 2017, and states that the amendment was not reviewed
prior to the FDA’s action. The FDA indicated that applicable
sections of the amendment submitted by Agile could be incorporated
when responding to deficiencies noted in the CRL.
“We are clearly disappointed, and we are evaluating the
FDA’s response,” said Al Altomari, chairman and chief executive
officer, Agile Therapeutics. “We intend to request a meeting
with the FDA as soon as possible to discuss the points raised in
the CRL and discuss a path to approval for Twirla. We will work
closely with the FDA to address the points raised in the CRL as
quickly as possible.”
Company to Host Conference Call
Agile Therapeutics will host a conference call on December 22,
2017 at 8:00 a.m. Eastern Time to discuss the Company’s
regulatory update. A question and answer session will follow Agile
Therapeutics’ remarks. To participate on the live call, please dial
(844) 413-1773 (domestic) or (678) 865-8976 (international), and
provide the conference ID number: 3979609.
A live audio webcast of the call will be available via the
“Investor Relations” page of the Agile Therapeutics website,
www.agiletherapeutics.com. Please log on through Agile
Therapeutics’ website approximately 10 minutes prior to the
scheduled start time. A replay of the webcast will be archived on
Agile Therapeutics’ website for 60 days following the call.
About Twirla® (AG200-15)Twirla
(levonorgestrel/ethinyl estradiol transdermal system) or AG200-15
is an investigational once-weekly prescription 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.
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 a 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 while optimizing patch adhesion and comfort for
the patient. 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 the Company's regulatory submissions. We
may, in some cases use terms such as "predicts," "believes,"
"potential," "continue," "anticipates," "estimates," "expects,"
"plans," "intends," "may," "could," “might," "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 involves risks, potential
changes in circumstances, assumptions, and uncertainties. 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. Our statements about our ability
to adequately and timely respond to the deficiencies in the Twirla
CRL issued by the FDA may be affected by whether any such response
will be accepted by the FDA, our ability and timing to resubmit the
NDA for Twirla, FDA acceptance and approval of the resubmitted NDA,
the FDA may require additional studies to address the concerns
raised in the CRL (for example, if it is determined that the
product adhesion concerns are due to the design or formulation of
the drug product, the FDA may recommend that we design a new
transdermal system and conduct another clinical trial with the new
transdermal system in a U.S. population), or whether other issues
will arise that will negatively impact acceptance, review, and
approval of Twirla by the FDA: our statements about the results of
our clinical trial could be affected by the potential that there
are changes in the interpretation of the data by the FDA (for
example, the FDA continues to question the number of pregnancies
included in our results and they may adjudicate additional
pregnancies); our statements about the potential commercial
opportunity could be affected by potential labeling restrictions,
the potential that our product does not receive regulatory
approval, does not receive reimbursement by third party payors, or
a commercial market for the product does not develop because of any
of the risks inherent in the commercialization of contraceptive
products. For all these reasons, actual results and
developments could be materially different from those expressed in
or implied by our forward-looking statements. All forward-looking
statements are subject to risks detailed in our filings with the
U.S. Securities and Exchange Commission, including the Company's
Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q.
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.
Investor Relations Contact:Mary Coleman Agile
Therapeutics609-356-1921
PR Contact:Kristin PehushLippe
Taylor212-598-4400
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