Dive Brief:
- Specialty pharma KemPharm Inc. on Thursday said it remains on track to submit its ADHD prodrug KP415 for approval as early as the end of 2018, calling a recent end of Phase meeting with the Food and Drug Administration "successful."
- KP415 is an extended release form of d-methylphenidate that uses KemPharm's LAT (ligand activated therapy) platform technology. The company claims the formulation may have lower abuse potential and less variable drug delivery.
- KemPharm will initiate a pivotal efficacy study of KP415 before the end of this year, aiming to prove an extended duration of therapy as well as an earlier onset of action for the drug.
Dive Insight:
The next step for KemPharm will be pushing KP415 into pivotal study to set up a future New Drug Application submission.
"The single ‘classroom-style’ pivotal efficacy trial is required to provide evidence for KP415 to support a potential labeled indication of both early onset of action and extended duration of therapy, both of which are unmet needs with current methylphenidate products," said KemPharm CEO Travis Mickle in a Nov. 16 statement.
While the ADHD market is a crowded one, companies continue to develop new products, many of which are different ways to deliver existing active ingredients. Shire plc's Mydayis (mixture of amphetamine salts), for example, was launched in August this year and is already picking up sales in the adult sector of the market —pegged by Shire as the fastest growing segment.
NLS Pharma AG expects to take its controlled release formulation of mazindol into Phase 3 in 2018, while Neurovance (now part of Otsuka Pharmaceutical Co., Ltd.) has a non-stimulant drug called centanafadine through Phase 2.
Elsewhere, Supernus Pharmaceuticals Inc.'s SPN-810 (molindone hydrochloride) is in Phase 3, with study focusing solely on the higher dose after a planned interim analysis.