KemPharm Announces Serdexmethylphenidate (SDX) Has Been Classified as a Schedule IV Controlled Substance by the DEA

KP879, KemPharm’s Lead Product Candidate Based on SDX and Intended for the Treatment of Stimulant Use Disorder (SUD), Could Be Schedule IV, If Approved by the FDA

CELEBRATION, Fla., May 07, 2021 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that serdexmethylphenidate (SDX), KemPharm’s proprietary prodrug of d-methylphenidate (d-MPH) and the primary active pharmaceutical ingredient (API) in AZSTARYS, has been classified as a Schedule IV controlled substance by the U.S. Drug Enforcement Administration (DEA). AZSTARYS is classified as a Schedule II controlled substance as it includes a 70:30 mixture of SDX (Schedule IV) and d-MPH (Schedule II), respectively.

According to the “Schedules of Controlled Substances: Placement of Serdexmethylphenidate in Schedule IV,” which has been published in the Federal Register (federalregister.gov/d/2021-09738), the DEA concluded that SDX meets the 21 U.S.C. 812(b)(4) criteria for placement in schedule IV of the Controlled Substances Act (CSA). This determination was based on an eight-factor analysis of the abuse potential, legitimate medical use, and dependence liability of SDX by the U.S. Department of Health and Human Services (HHS), which concluded that “SDX is related in action and effect to the schedule IV substance phentermine, and can therefore be expected to have a similar potential for abuse.” Notably, in its report, HHS affirmed that “in clinical studies, SDX demonstrated a lower potential for abuse when compared to d-MPH,” a Schedule II controlled substance under the CSA.
  
“We are pleased with the publication of the analysis conducted by HHS and the DEA’s decision to classify SDX as a Schedule IV controlled substance, affirming our research which indicated SDX has a lower potential for abuse when compared to d-MPH,” stated Travis C. Mickle, Ph.D., President and CEO of KemPharm. “We believe the combination of the AZSTARYS product label received at approval, the Schedule IV designation for SDX and the economic terms of the recently announced amendment to our Licensing Agreement with GPC will provide the opportunity to generate substantial value for KemPharm for many years to come.”