The resubmission, which provides information to specifically address the FDA-issued complete response letter received in September 2013, includes the results from an additional pharmacokinetic trial that was conducted with NT-0202 using a commercial-scale manufacturing process and the requisite stability data.
Neos president and CEO Vipin Garg said: "Our product candidates incorporate two of the most commonly prescribed medications for the treatment of ADHD, methylphenidate and amphetamine."
The Class 2 resubmission has a target six-month PDUFA review period. If approved, NT-0202 will be the first amphetamine XR-ODT for ADHD.
The company’s 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 ADHD treatment.
"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," Garg added.
According to the company, stimulant medications such as methylphenidate and amphetamine are the standard of care for treating ADHD, while XR formulations of these medications allow for once-daily dosing.