October 20, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Dallas/Fort Worth, Texas-based Neos Therapeutics announced yesterday that the U.S. Food and Drug Administration (FDA) had found deficiencies in its New Drug Application (NDA) for Cotempla XR-ODT to treat attention deficit hyperactivity disorder (ADHD). As a result, they would not be discussing labeling and postmarketing requirements until further review.
Neos focuses on developing and commercializing drugs that use the company’s extended-release drug delivery technology platform. Currently its three product candidates are for ADHD. The technology, XR-ODT, is a Rapidly Disintegrating Ionic Masking (RDIM) platform, which the company indicates on its website is “an oral-disintegrating, extended-release, taste-masked pharmaceutical composition that can withstand compression forces associated with standard tableting technology.”
In terms of ADHD, the company points out that much of the pediatric population has difficulties swallowing pills and tablets, and many adults do as well. Orally Disintegrating Tablets (ODTs) are designed to dissolve on the tongue without water.
“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,” said Vipin Garg, president and chief executive officer of Neos, in a statement. “We look forward to moving ahead with our plan to bring the benefits of Cotempla XR-ODT and our two additional product candidates to patients with ADHD as potential novel treatment options.”
Neos resubmitted the NDA on July 30, 2015. It had received a Complete Response Letter from the FDA in September 2013, which requested additional pharmacokinetic study. The resubmission was a Class 2, with a target six-month PDUFA review period.
“Our product candidates incorporate two of the most commonly prescribed medications for the treatment of ADHD, methylphenidate and amphetamine,” said Garg in a July statement. “Our proprietary modified-release drug delivery technology platform has enabled us to combine two key drug delivery attributes in each of these product candidates: an extended-release profile, which allows for once-daily dosing, and an ODT dosage form, which disintegrates in the mouth, without the need for water.”
The company released its second quarter financial report on Sept. 3. Total revenues for the quarter were $1.5 million, up by $1.4 million from the same period in 2014. The product revenue was entirely generated from net sales of the company’s generic Tussionex.
Research and development costs for the quarter were $2.1 million, $1.1 million less than the same period in 2014, primarily the result of fewer clinical expenses and the completion of a classroom efficacy study of NT-0102 and the finalizing of clinical trials for NT-0201 and NT-0202 in 2014.
Neos dropped at the news. Shares traded on July 24, 2015 for $20.51, rose to $27.09 on Aug. 28, then dropped to $18.02 on Sept. 28. Share price improved slightly to $21.17 on Oct. 5, and is currently trading for $13.80.
The FDA notice, however, states that this is not a final decision on Cotempla. A final decision is scheduled for Nov. 9, 2015. The company’s NDA for NT-0202 for ADHD has a decision date of Jan. 27, 106.
