Naldemedine NDA Submitted for Opioid-Induced Constipation
Shionogi announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for naldemedine 0.2mg once daily tablet for the treatment of opioid-induced constipation (OIC).
Naldemedine previously demonstrated its efficacy in Phase 3 clinical trials (COMPOSE program) in patients with OIC. The proposed indication for naldemedine in the U.S. is for the treatment of OIC in adult patients with chronic non-cancer pain.
OIC is characterized by reduced bowel movement frequency, development or worsening of straining to pass bowel movements, a sense of incomplete rectal evacuation, or harder stool consistency after initiating opioid therapy.
Naldemedine is an investigational, oral, peripherally acting mu-opioid receptor antagonist (PAMORA).
For more information call (800) 849–9707 or visit Shionogi.com.