Agile Therapeutics Announces FDA Acceptance of the NDA Resubmission of Twirla®
July 27 2017 - 4:12PM
Agile Therapeutics, Inc. (Nasdaq:AGRX), a forward-thinking women’s
healthcare company, today announced that the U.S. Food and
Drug Administration (FDA) has accepted for review the Company’s New
Drug Application (NDA) resubmission for Twirla® (AG200-15), an
investigational low-dose combined hormonal contraceptive
patch. The NDA resubmission was submitted on June 26, 2017
and is intended to address a Complete Response Letter (CRL) issued
by the FDA in February 2013, which recommended that Agile conduct a
new clinical trial and provide additional information on the
manufacturing process for Twirla. The FDA stated that it considers
the resubmission to be a complete response to the CRL and
established December 26, 2017 as the Prescription Drug User Fee Act
(PDUFA) goal date.
“We are pleased that the FDA has acknowledged
our NDA resubmission as a complete response to the CRL. The
acceptance of our data package for substantive review represents a
significant milestone for the Company and we look forward to
continuing to work with the FDA during their review,” said Al
Altomari, Chairman and Chief Executive Officer of Agile. “Now that
we have received our expected PDUFA goal date, we intend to turn
our full attention to implementing our commercialization plans for
Twirla, if approved, and continue to work towards our goal of
offering women a new low-dose contraceptive patch.”
About Agile Therapeutics
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®, (ethinyl estradiol and levonorgestrel
transdermal system), also known as AG200-15, is a once-weekly
prescription contraceptive patch that recently completed Phase 3
trials. Twirla is based on our proprietary transdermal patch
technology, called Skinfusion®, which is designed to provide
advantages over currently available patches and is intended to
optimize patch adhesion and patient wearability. For more
information, please visit the company website at
www.agiletherapeutics.com. Follow Agile on social media:
@agilether. The company may occasionally disseminate
material, nonpublic information on the company website.
About Twirla®
Twirla (ethinyl estradiol and levonorgestrel
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 synthetic estrogen, and levonorgestrel
(LNG), a type of progestin, a synthetic steroid hormone. Twirla is
designed to be applied once weekly for three weeks, followed by a
week without a patch.
Forward-Looking Statement
Certain 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 the results
and conduct of our clinical trial could be affected by the
potential that there are changes in the data or interpretation of
the data by the FDA (for example, the FDA may include additional
pregnancies in its calculation of the Pearl Index, which would
increase the Pearl Index), whether the results will be deemed
satisfactory by the FDA (for example, we may describe the results
of the SECURE trial as positive, the FDA may disagree with that
characterization), and whether additional studies will be required
or other issues will arise that will negatively impact review and
approval of Twirla by the FDA; our statements about the potential
commercial opportunity could be affected by 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.
Contact:
Mary Coleman
Investor Relations
Agile Therapeutics, Inc.
E: mcoleman@agiletherapeutics.com
P: 609-683-1880
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