Neos Therapeutics, Inc., a Texas-based pharmaceutical company focused on extended-release drug delivery technologies for the treatment of attention deficit hyperactivity disorder (ADHD), recently announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) concerning the review of the New Drug Application (NDA) for the company’s product Cotempla XR-ODT™.
A CRL is issued after the FDA has completed its review of a drug candidate’s application, but some questions remain that preclude the application’s approval in its current form.
ADHD is one of the most common disorders in children, being characterized by difficulties in staying focused, in controlling behavior, and by impulsivity and hyperactivity. Cotempla XR-ODT (Methylphenidate Extended Release Orally Disintegrating 10 mg, 20 mg, and 30 mg tablets) is based on methylphenidate, a standard of care for ADHD treatment. The drug is formulated as an extended release medication, allowing it to be available as a once-daily dosing.
The FDA had previously reported deficiencies in the Cotempla XR-ODT application that prevented further discussion on labeling and post-marketing of the drug. At the time, however, the nature of the deficiencies was not disclosed.
The FDA’s Center for Drug Evaluation and Research has provided Neos Therapeutics with the questions to be addressed. According to the CRL, Neos Therapeutics needs to perform a bridging study showing the bioequivalence between the clinical trial material and the drug candidate, including an evaluation of food effect, and provide validation and three months of stability data. The FDA’s CRL did not indicate any efficacy or safety issues with the clinical data already provided by the company on Cotempla XR-ODT.
“We remain committed to commercializing Cotempla XR-ODT and will work closely with the FDA to address the deficiencies identified in the CRL,” said Dr. Vipin K. Garg, President and CEO of Neos Therapeutics, in a news release.
Besides Cotempla XR-ODT, the company also developed an amphetamine XR-ODT drug candidate as a potential therapy for ADHD called NT-0202. The product is currently under revision by the FDA and has a Prescription Drug User Fee Act (PDUFA) date set for Jan. 27, 2016.
“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, ” said Dr. Garg.
Neos Therapeutics also disclosed its financial results for the third quarter of 2015, which ended on Sept. 30. Those results can be read in this news release.