Sublocade Injectable Approved for Opioid Use Disorder
November 30, 2017 – The U.S. FDA has approved Sublocade™ (buprenorphine), manufactured by Indivior, to treat moderate-to-severe opioid use disorder (OUD) in adults. Patients who are prescribed Sublocade under this indication must already have been on a stable dose of buprenorphine via a transmucosal (absorbed through mucus membranes) delivery system for at least seven days.
Sublocade is the first injectable buprenorphine treatment option for moderate-to-severe OUD. Other existing buprenorphine formulations include tablets, dissolvable films, and implants. Recommended initial dosing with Sublocade is 300mg once per month, via subcutaneous injection in the abdominal region. Patients should subsequently receive 100mg per month for maintenance treatment, though the prescriber can increase the dosage up to 300mg per month if necessary. Sublocade must be administered by a healthcare professional, and should only be used in conjunction with a complete treatment program, including services such as counseling and psychosocial support, to facilitate patient recovery.
A black box warning cautions that Sublocade can be fatal or cause serious harm if given intravenously. The drug is available through a restricted risk evaluation and mitigation strategy (REMS) program, meaning that pharmacies and healthcare providers who order and dispense Sublocade must have appropriate certification and abide by REMS requirements.
Launch is expected during the first quarter of 2018. Sublocade will be available in 100mg/5mL and 300mg/1.5mL syringes, at an expected wholesale acquisition cost of $1,580 per month for each.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.