naldemedine

FDA Drug Profile — SYMPROIC

Drug Details

Generic Name
naldemedine
Brand Names
SYMPROIC
Application Number
NDA208854
Sponsor
BioDelivery Sciences International Inc
NDC Codes
1
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
NALDEMEDINE TOSYLATE

Indications and Usage

1 INDICATIONS AND USAGE SYMPROIC is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. SYMPROIC is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation ( 1 )