Neos Therapeutics Submits NDA for Amphetamine Extended-Release Liquid Suspension Drug Candidate, NT-0201, for the Treatment o...
November 17 2016 - 8:00AM
Neos Therapeutics, Inc. (NASDAQ:NEOS), a pharmaceutical company
focused on developing and commercializing innovative
extended-release (XR) products for the treatment of
attention-deficit hyperactivity disorder (ADHD), announced today
that it has submitted a New Drug Application (NDA) to the U.S. Food
and Drug Administration (FDA) for its Amphetamine XR oral
suspension drug candidate, NT-0201, an ADHD medication based on its
proprietary modified‐release drug delivery technology platforms.
“This NDA submission for NT-0201 is another
important milestone for our company, as we continue to build out
our ADHD product portfolio,” said Vipin K. Garg, Ph.D., President
and CEO of Neos Therapeutics. “Additionally, we expect to resubmit
the NDA for Cotempla XR-ODT™, our methylphenidate extended-release
orally disintegrating tablet, this quarter. By the fall of 2017,
with NT-0201 and Cotempla XR-ODT, if approved, and our already
marketed product, Adzenys XR-ODT, we hope to offer patient-friendly
treatment options for both of the stimulant medications that are
most widely prescribed for the treatment of ADHD.”
NT-0201 is the company’s second extended-release
amphetamine product candidate for the treatment of ADHD. The first,
an extended-release orally disintegrating tablet, Adzenys XR-ODTTM,
was approved by the FDA in January and was launched in May 2016.
NT-0201 is a once-daily, extended-release liquid medication that
does not require refrigeration or reconstitution at the pharmacy
level. If approved, NT-0201 is designed to provide an additional
treatment option for patients with ADHD.
About Neos Therapeutics
Neos Therapeutics, Inc. is a pharmaceutical
company focused on developing, manufacturing and commercializing
products utilizing its proprietary modified‐release drug delivery
technology platforms. Adzenys XR-ODTTM, indicated for the treatment
of ADHD in patients 6 years of age and older, is the first approved
product using the Company’s XR-ODT technology platform. Neos,
which is initially focusing on the treatment of ADHD, has two other
branded product candidates that are XR medications in ODT or oral
suspension dosage forms. In addition, Neos manufactures
and markets its generic equivalent of the branded product
Tussionex®1, an XR oral suspension of hydrocodone and
chlorpheniramine indicated for the relief of cough and upper
respiratory symptoms of a cold.
1Tussionex® is a registered trademark of
the UCB Group of Companies.
Forward-Looking Statements This
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of
1995, including statements concerning the capabilities of NT-0201,
the resubmission of the NDA for Cotempla XR-ODTTM, the
commercialization of the Company’s products and product candidates
and the development of the Company’s future product
candidates. Forward-looking statements generally relate to
future events or our future financial or operating performance. In
some cases, you can identify forward-looking statements because
they contain words such as "may," "will," "should," "expects,"
"plans," "anticipates," "could," "intends," "target," "projects,"
"contemplates," "believes," "estimates," "predicts," "potential" or
"continue" or the negative of these words or other similar terms or
expressions that concern our expectations, strategy, plans,
prospects or intentions. These forward-looking statements
reflect our current views about our expectations, strategy, plans,
prospects or intentions, which are based on the information
currently available to us and on assumptions we have
made. We caution you that the foregoing may not be the
only the forward‐looking statements made in this press
release. You should not rely upon forward‐looking statements
as predictions of future events. These forward‐looking statements
involve risks, uncertainties, assumptions and other factors that
are difficult to predict and that could cause actual results to
differ materially from what is expressed in or indicated by the
forward‐looking statement, including the receipt of regulatory
approval for Cotempla XR-ODT and NT-0201, our ability to
market and sell our product candidates, our ability to raise
capital when needed and other risks set forth under the caption
“Risk Factors” in our most recent Quarterly Report on Form 10-Q, as
updated by our other subsequently filed SEC filings.
Contacts:
Richard Eisenstadt
Chief Financial Officer
Neos Therapeutics
(972) 408-1389
reisenstadt@neostx.com
Sarah McCabe
Stern Investor Relations, Inc.
(212) 362-1200
sarah@sternir.com
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