KemPharm Announces Positive Topline Results from Oral Human Abuse Potential Trial of KP415 Prodrug

KemPharm (NASDAQ:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced topline results from its oral human abuse potential (HAP) clinical trial of serdexmethylphenidate (SDX, a prodrug of d-methylphenidate, or KP415 Prodrug), the major active pharmaceutical ingredient (API) in KP415, its investigational ADHD product candidate that also contains d-methylphenidate.

As quoted in the press release:

Results from the oral HAP trial (KP415.A01) indicate that the prodrug component of KP415 may have lower abuse potential compared to Focalin XR (d-methylphenidate extended release capsules), a schedule II controlled substance, even when SDX is administered at oral doses up to 1.5 times higher than Focalin^® XR on a molar basis.

“The positive results from the oral HAP trial of SDX are another important milestone in the ongoing development of KP415 as we continue to advance a product candidate with properties that are clearly differentiated from currently marketed methylphenidate ADHD treatments, and with respect to abuse potential, perhaps all ADHD stimulant treatments,” said Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “Reducing the abuse potential of stimulant-based ADHD medications is viewed by prescribers as a key unmet need.  The oral HAP data are especially meaningful because we observed that SDX had lower Drug Liking at a higher dose, 240 mg, than an extended-release d-methylphenidate product.  It is quite unique to use an extended release comparator in these studies and simultaneously observing such a dramatic difference in effect, especially with a higher equivalent dose of stimulant. Additionally, SDX at 120 mg produced lower Drug Liking than phentermine, a schedule IV controlled substance.  These results together with the previously reported intravenous HAP data, suggest that SDX, the prodrug in both KP415 and KP484 product candidates, produces pharmacodynamic effects that are far less desirable to abusers in comparison to d-methylphenidate either when injected or taken orally as Focalin^® XR, an extended release comparator, at supratherapeutic doses.”

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