FDA finds mystery 'deficiencies' with Neos' long-acting Ritalin on the eve of approval

  • biotechnology industry,biotech company,clinical trials,Neos Therapeutics,Regulatory

Neos Therapeutics ($NEOS) got an ominous note from the FDA just weeks ahead of the expected approval date for its long-acting ADHD treatment, clouding the future of the company's lead asset.

The drug, Cotempla XR-ODT, is an extended-release formulation of the active ingredient in Ritalin and other ADHD treatments, and it's slated for a final FDA decision by Nov. 9.

On Friday, Neos got word from regulators that, while reviewing Cotempla, the FDA "identified deficiencies that preclude discussion" of the drug's future label, the company said. The agency said the problem does not reflect its final opinion on Cotempla, according to Neos, but that's all the company knows about the issue, management said.

"Although the FDA has not provided us with any information regarding the nature of the deficiencies, we intend to work closely with the FDA to understand the nature of any such deficiencies once identified to us and resolve them as quickly as possible," Neos CEO Vipin Garg said in a statement.

Investors read the note as an troubling sign for Neos and its most-advanced drug, sending the company's shares down as much as 25% after hours on Tuesday.

Neos executed a $72 million IPO over the summer based in part on the potential of Cotempla, a formulation of methylphenidate designed to last for 12 hours. In filings with the SEC, Neos disclosed that the FDA inspected its production facility in May and cited it for a single instance of inadequate controls related to its computer systems. Neos said it responded to the agency in June and has corrected its system "to assure that changes in records are instituted only by authorized personnel."

Behind Cotempla, Neos' pipeline includes an extended-release formation of amphetamine, which is up for a final FDA decision in January.


This link:http://www.chemcd.com/news/19373.html

The ChemCD compiler finishing, shall not be reproduced without permission, for reprint please indicate the source。

comments powered by Disqus

Categories

Related News

Pfizer's once-failed cancer drug wins the FDA's 'breakthrough' tag

2015/10/20 - Pfizer has found new hope for a former pipeline standout, picking up the FDA's coveted breakthrough therapy designation for a Phase III reclamation project in oncology.

Puma Biotechnology Announces Positive Top Line Results from Phase III PB272 Trial in Adjuvant Breast Cancer (ExteNET Trial)

2014/07/25 - Puma Biotechnology, Inc. a development stage biopharmaceutical company, announced top line results from the Phase III clinical trial of Puma's investigational drug PB272 (neratinib) for the extended adjuvant treatment of breast cancer (ExteNET Trial).

Pfizer strikes another immunotherapy deal to widen its oncology pipeline

2014/12/10 - Pfizer has agreed to pay iTeos Therapeutics €24 million ($30 million) up front for the exclusive rights to some preclinical candidates, also making an undisclosed equity investment in the company and promising untold milestone payments down the line.

AstraZeneca announces top-line results from the Phase III programme of lesinurad in combination with xanthine oxidase inhibitors in gout patients

2014/08/13 - AstraZeneca today announced positive top-line results from CLEAR1, CLEAR2 and CRYSTAL, the pivotal Phase III clinical trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor (SURI), as a combination therapy for the treatment of patients with symptomatic gout.

Pfizer Completes Acquisition Of InnoPharma

2014/09/26 - Pfizer Inc. (PFE) today announced that it has completed its acquisition of the pharmaceutical development company, InnoPharma, Inc., following receipt of United States (U.S.) regulatory approval from all government authorities required by the agreement and other closing conditions.

Alnylam Receives Orphan Drug Designations in the European Union for ALN-AT3, an RNAi Therapeutic in Development for the Treatment of Hemophilia

2014/08/11 - Alnylam Pharmaceuticals, Inc. (ALNY), a leading RNAi therapeutics company, announced today that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has granted Orphan Drug Designations for ALN-AT3 as an orphan medicinal product for the treatment of hemophilia A and hemophilia B.