Pharmaceutical Business review

MonoSol Rx, KemPharm to jointly develop ADHD drug

KP106 is composed of d-amphetamine and a ligand.

In clinical studies, KP106 demonstrated pharmacokinetics indicative of an attenuated amphetamine exposure as compared to Vyvanse.

MonoSol Rx will have a significant financial stake in KP106 and will be the exclusive manufacturer.

It will also be eligible for development milestone payments.

MonoSol Rx president and CEO Mark Schobel said their PharmFilm platform matches well with KP106 and will provide a patent protected, convenient and innovative alternative to other ADHD products on the market.

"Our dosage form, in conjunction with KemPharm’s KP106, has the potential to offer a safer, abuse-resistant and more effective treatment option for ADHD, which is particularly important given the concerns of patients, parents and caregivers regarding the risks associated with currently marketed ADHD drugs," Schobel said.

KemPharm projects the filing of a new drug application for KP106 by the end of 2012.