MonoSol Rx Announces Second PharmFilm Product


MonoSol Rx, LLC recently announced it plans to develop a second oral film product for the treatment of attention-deficit hyperactivity disorder (ADHD) with its partner KemPharm, Inc. KP415, which was recently discovered by KemPharm, is a novel prodrug of methylphenidate, a commonly used medication for the treatment of ADHD.

The companies plan to co-develop the oral film dosage form of KP415 under a previously established exclusive technology and manufacturing partnership, which also currently includes KP106, a pro-drug of d-amphetamine. If approved, these drug candidates will be the first oral film products for the treatment of ADHD, which consist primarily of a pediatric patient population.

“The addition of KP415 to our partnership with KemPharm provides us with a portfolio of highly differentiated products for treating ADHD,” said A. Mark Schobel, Co-President and CEO of MonoSol Rx. “We believe delivery of KP415 and KP106, using our patented PharmFilm technology, significantly improves the convenience with which these novel molecules, which represent two major classes of drugs used to treat ADHD, can be dosed. This may improve patient compliance and therapeutic outcomes. We look forward to working closely with KemPharm to advance these programs and to commercializing the first ADHD treatments using oral film drug delivery.”

“We share our enthusiasm about the discovery of KP415 with our partners at MonoSol Rx,” added Travis C. Mickle, PhD, President and CEO of KemPharm. “Along with KP106, our diversified, next-generation ADHD portfolio has the potential to change the way this disorder is treated by creating novel prodrugs with the potential to improve upon existing therapies in clinically meaningful ways.”

Under terms of the agreement, the companies will co-develop and commercialize KemPharm’s KP415 and KP106 utilizing MonoSol Rx’s PharmFilm delivery platform. MonoSol Rx will be the exclusive manufacturer and be eligible for development milestone payments.