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Neos Therapeutics Resubmits New Drug Application for FDA Review of Amphetamine Extended-Release Orally Disintegrating Tablets to Treat ADHDNeos 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 it has resubmitted a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for its amphetamine XR orally disintegrating tablet ("XR-ODT") product candidate, NT-0202, for the treatment of ADHD. The NT-0202 NDA resubmission provides information to specifically address the FDA-issued Complete Response Letter received in September 2013. This includes the results from an additional pharmacokinetic study which was conducted with NT-0202 that utilized a commercial-scale manufacturing process, and the requisite stability data. This submission is a Class 2 resubmission, with a target six-month PDUFA review period. If approved, NT-0202 will be the first amphetamine XR-ODT for ADHD. Neos' methylphenidate XR-ODT candidate, Cotempla XR-ODT™, is currently under review by the FDA and, if approved, will be the first methylphenidate XR-ODT available for the treatment of ADHD. "Our product candidates incorporate two of the most commonly prescribed medications for the treatment of ADHD, methylphenidate and amphetamine. 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," said Vipin K. Garg, Ph.D., President and CEO of Neos. About XR-ODT Technology Stimulant medications such as methylphenidae and amphetamine are the standard of care for treating ADHD, and XR formulations of these medications allow for once-daily dosing. However, recent data suggest that a significant percentage of the pediatric population have difficulty swallowing solid dosage forms, and many remain uncomfortable doing so into adulthood. ODTs differ from traditional tablets and capsules in that they are designed to disintegrate on the tongue without the need for water, rather than being swallowed whole. About ADHD According to the National Institute of Mental Health, ADHD is one of the most common childhood disorders and can continue through adolescence and adulthood. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior and hyperactivity (over-activity). 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 ADHD and has developed three branded product candidates that are XR medications in patient-friendly ODT or liquid suspension dosage forms. In addition, Neos manufactures and markets its generic equivalent of the branded product Tussionex®1, an XR liquid suspension of hydrocodone and chlorpheniramine indicated for the relief of cough and upper respiratory symptoms of a cold. Special Note Regarding Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the federal securities laws and these statements involve substantial risks and uncertainties. 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 or intentions. Forward-looking statements contained in this press release include, but are not limited to, statements about the PDUFA date for Cotempla XR- ODT™ and pharmacokinetic profile, extended-release properties and tolerability of our product candidates, including Cotempla XR-ODT™ and NT-0202. 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. 1 Tussionex® is a registered trademark of the UCB Group of Companies View source version on businesswire.com: http://www.businesswire.com/news/home/20150730005296/en/ |
