DALLAS, TX & FORT WORTH, TX, USA I July 30, 2015 I 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 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 methylphenidate 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.
SOURCE: Neos Therapeutics
Post Views: 21
DALLAS, TX & FORT WORTH, TX, USA I July 30, 2015 I 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 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 methylphenidate 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.
SOURCE: Neos Therapeutics
Post Views: 21
