Zydus Lifesciences' Sentynl Therapeutics Gets FDA Acceptance for CUTX-101 NDA Resubmission

Sentynl Therapeutics, a subsidiary of Zydus Lifesciences Ltd, has announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for CUTX-101. This acceptance indicates that the FDA has found the resubmission sufficient to permit a complete review. CUTX-101 is a novel, proprietary, extended-release, oral formulation of oxymorphone, a potent opioid agonist, for the management of moderate-to-severe pain in adults. The FDA had previously issued a Complete Response Letter (CRL) for the NDA in October 2021, requesting additional information. Sentynl Therapeutics resubmitted the NDA in April 2022, addressing all the issues raised in the CRL.