KemPharm Announces Serdexmethylphenidate (SDX) Has Been Classified as a Schedule IV Controlled Substance by the 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.\nAccording to the \xe2\x80\x9cSchedules of Controlled Substances: Placement of Serdexmethylphenidate in Schedule IV,\xe2\x80\x9d which has been published in the Federal Register (federalregister.gov/d/2021-09738), the DEA concluded that SDX meets the 21 U.S.C.
- 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.\nAccording to the \xe2\x80\x9cSchedules of Controlled Substances: Placement of Serdexmethylphenidate in Schedule IV,\xe2\x80\x9d 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).
- \xe2\x80\x9cKP879, which is intended for the treatment of stimulant use disorder, is based on SDX as the sole API.
- KemPharm\xe2\x80\x99s lead clinical development candidate for the treatment of SUD, KP879, is based on its prodrug of d-methylphenidate, known as serdexmethylphenidate (SDX).