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Cotempla XR-ODT

Generic name: methylphenidate
Treatment for: Attention-Deficit/Hyperactivity Disorder (ADHD)

Neos Therapeutics Receives Complete Response Letter From the FDA for Cotempla XR-ODT

DALLAS and FORT WORTH, Texas, Nov. 10, 2015 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (Nasdaq:NEOS), a pharmaceutical company with a late‐stage pipeline of innovative extended-release (XR) product candidates for the treatment of attention deficit hyperactivity disorder (ADHD), today announced that the Company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company's New Drug Application (NDA) for Cotempla XR-ODT™ (Methylphenidate Extended Release Orally Disintegrating) 10mg, 20mg, and 30mg tablets. Neos Therapeutics also announced financial results for the third quarter ended September 30, 2015.

Complete Response Letter from the FDA for Cotempla XR-ODT

As the Company previously disclosed, the Company was informed on October 16, 2015 that the FDA had identified unspecified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments, and had set November 9, 2015 as the Prescription Drug User Fee Act (PDUFA) goal date for a decision on the NDA.

A CRL is issued by the FDA's Center for Drug Evaluation and Research when it has completed its review of an NDA and questions remain that preclude the approval of the NDA in its current form. The CRL for Cotempla XR-ODT™ requires the Company to conduct a bridging study to demonstrate bioequivalence between the clinical trial material and to-be-marketed drug product, including an assessment of food effect, and to provide validation and three months of stability data. The FDA did not raise any safety or efficacy issues with the clinical data previously provided beyond the need for an adequate bridge between the clinical trial material and the to-be-marketed drug product.

"We remain committed to commercializing Cotempla XR-ODT™ and will work closely with the FDA to address the deficiencies identified in the CRL," said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics. "We have a strong cash position and remain on track with the development of our other lead product candidate, NT-0202. Assuming a positive decision from the FDA surrounding our January 27, 2016 PDUFA date, we plan to accelerate commercialization of NT-0202 from the third quarter of 2016 to the second quarter of 2016." NT-0202, Neos' amphetamine XR-ODT product candidate for the treatment of ADHD, currently has a PDUFA goal date of January 27, 2016 as set by the FDA. Neos also manufactures and markets a generic equivalent to the branded product Tussionex®1.

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 platform. The Company is initially focusing on the treatment of ADHD and has developed three branded product candidates that are XR medications in patient‐friendly ODT or liquid suspension dosage forms. In addition, Neos Therapeutics manufactures and markets its generic equivalent of the branded product Tussionex, an XR liquid suspension of hydrocodone and chlorpheniramine indicated for the relief of cough and upper respiratory symptoms of a cold.

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 our ability to commercialize Cotempla XR-ODT™ and the PDUFA date for NT‐0202 and capabilities of our XR-ODT 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. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, our ability to successfully address the deficiencies identified by the FDA or which may be identified by the FDA which preclude approval of the NDA for our Cotempla XR-ODT™ product candidate, including that we demonstrate bioequivalence between the clinical trial material and to-be-marketed drug product and that we assess the food effect on the to-be-marketed drug product, the receipt of regulatory approval for NT-0202, our ability to market and sell our product candidates, and other risks set forth under the caption "Risk Factors" in our final prospectus filed on July 24, 2015 pursuant to Rule 424(b) of the Securities Act of 1933, as amended, as updated by our subsequently filed Quarterly Reports on Form 10-Q and our other SEC filings. We assume no obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

1 Tussionex® is a registered trademark of the UCB Group of Companies

Source: Neos Therapeutics, Inc.

Posted: November 2015

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