KP484 Designed to be a Predictably Dosed, Super-Extended Release, Methylphenidate Product
CORALVILLE, IA, USA I September 20, 2017 I KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin human clinical trials of KP484, the Company’s prodrug product candidate of “super-extended” release d-methylphenidate (d-MPH) for the treatment of attention deficit hyperactivity disorder (ADHD).
“In the process of re-analyzing the Phase 1 data for KP415, our co-lead investigation prodrug of d-MPH for the treatment of ADHD, we observed properties and a drug release profile in KP484 that we believe allows for the possible development of a much longer acting form of the molecule that, if approved, separate and apart from KP415, may enable us to target an underserved group of ADHD patients,” said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “We believe both KP484 and KP415 have features that could provide certain benefits when compared with other FDA-approved and widely prescribed methylphenidate products. Pharmacokinetic data from our studies suggest that the time to maximum plasma concentration of our prodrug of methylphenidate after oral administration is approximately three times longer compared to immediate release methylphenidate, which may allow for convenient, once-daily dosing.”
“Operationally designated KP484,” Dr. Mickle continued, “the data observed suggests that the prodrug may produce a longer duration release of d-MPH relative to comparator products available on the market today. We believe this longer acting property – or “Super-Extended Release” – may be well-suited for the unique treatment needs of the adult ADHD population.”
KemPharm’s IND proposal is to develop KP484 along a similar clinical trial pathway as KP415, with efficacy studies of KP484 initiating in 2018. It is anticipated that data for KP484 will be leveraged from current and ongoing KP415 research, including pharmacokinetic and human abuse liability studies, which could allow an expedited development timeline towards a potential New Drug Application (NDA) submission with the FDA as early as 2019. KemPharm believes that the ability to develop multiple prodrugs from the same Active Pharmaceutical Ingredient with unique treatment benefits and commercial profiles is the hallmark of its Ligand Activated Therapy (LAT™) prodrug discovery platform.
About KemPharm
KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its LATTM (Ligand Activated Therapy) platform technology. KemPharm utilizes its LATTM platform technology to generate improved prodrug versions of FDA-approved drugs in the high need areas of pain, ADHD and other central nervous system disorders. KemPharm’s co-lead clinical development candidates are KP415 and KP484, both based on a prodrug of methylphenidate, but with differing extended-release profiles for the treatment of ADHD, and KP201/IR, an acetaminophen-free formulation of the company’s immediate release abuse deterrent hydrocodone product candidate, KP201. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com.
SOURCE: KemPharm
Post Views: 22
KP484 Designed to be a Predictably Dosed, Super-Extended Release, Methylphenidate Product
CORALVILLE, IA, USA I September 20, 2017 I KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin human clinical trials of KP484, the Company’s prodrug product candidate of “super-extended” release d-methylphenidate (d-MPH) for the treatment of attention deficit hyperactivity disorder (ADHD).
“In the process of re-analyzing the Phase 1 data for KP415, our co-lead investigation prodrug of d-MPH for the treatment of ADHD, we observed properties and a drug release profile in KP484 that we believe allows for the possible development of a much longer acting form of the molecule that, if approved, separate and apart from KP415, may enable us to target an underserved group of ADHD patients,” said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “We believe both KP484 and KP415 have features that could provide certain benefits when compared with other FDA-approved and widely prescribed methylphenidate products. Pharmacokinetic data from our studies suggest that the time to maximum plasma concentration of our prodrug of methylphenidate after oral administration is approximately three times longer compared to immediate release methylphenidate, which may allow for convenient, once-daily dosing.”
“Operationally designated KP484,” Dr. Mickle continued, “the data observed suggests that the prodrug may produce a longer duration release of d-MPH relative to comparator products available on the market today. We believe this longer acting property – or “Super-Extended Release” – may be well-suited for the unique treatment needs of the adult ADHD population.”
KemPharm’s IND proposal is to develop KP484 along a similar clinical trial pathway as KP415, with efficacy studies of KP484 initiating in 2018. It is anticipated that data for KP484 will be leveraged from current and ongoing KP415 research, including pharmacokinetic and human abuse liability studies, which could allow an expedited development timeline towards a potential New Drug Application (NDA) submission with the FDA as early as 2019. KemPharm believes that the ability to develop multiple prodrugs from the same Active Pharmaceutical Ingredient with unique treatment benefits and commercial profiles is the hallmark of its Ligand Activated Therapy (LAT™) prodrug discovery platform.
About KemPharm
KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its LATTM (Ligand Activated Therapy) platform technology. KemPharm utilizes its LATTM platform technology to generate improved prodrug versions of FDA-approved drugs in the high need areas of pain, ADHD and other central nervous system disorders. KemPharm’s co-lead clinical development candidates are KP415 and KP484, both based on a prodrug of methylphenidate, but with differing extended-release profiles for the treatment of ADHD, and KP201/IR, an acetaminophen-free formulation of the company’s immediate release abuse deterrent hydrocodone product candidate, KP201. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com.
SOURCE: KemPharm
Post Views: 22
