SDR041

SDR041 is an investigational abuse-deterrent, immediate-release formulation of the fixed-dose combination hydrocodone bitartrate and acetaminophen, developed by Sun Pharma Advanced Research Company Limited (SPARC) for the management of moderate to severe pain. Hydrocodone is a semi-synthetic opioid agonist that binds to mu-opioid receptors in the central nervous system to provide analgesia, while acetaminophen is a non-opioid analgesic and antipyretic that inhibits prostaglandin synthesis. SDR041 is engineered with physical and chemical barriers intended to make the tablet difficult to crush, snort, or inject, thereby reducing its potential for non-medical use and abuse compared to conventional immediate-release formulations like Norco. The formulation aims to maintain the therapeutic efficacy and bioequivalence of standard hydrocodone/acetaminophen combinations while incorporating safety features to discourage tampering.

Other names

Hydrocodone bitartrate + acetaminophen abuse-deterrentHydrocodone/Acetaminophen SPARC