HUNT VALLEY, MD, SEPTEMBER 5, 2023—Pharmaceutics International, Inc. (Pii), a contract development and manufacturing organization (CDMO), is proud to recognize FDA’s approval of Braeburn’s BRIXADITM (buprenorphine) extended-release subcutaneous injection (CIII), a weekly and monthly medication for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a transmucosal buprenorphine-containing product. BRIXADI should be used as part of a complete treatment plan that includes counseling and psychosocial support. Because of the risk of serious harm resulting from accidental intravenous (IV) administration, BRIXADI has a Boxed Warning and will be made available through a restricted distribution program called the BRIXADI Risk Evaluation and Mitigation Strategy (REMS). Pii is honored for the role it continues to play in supporting the development, scale-up, and commercialization of BRIXADITM and looks forward to assisting Braeburn in the US launch of the medication.

The National Institutes of Health estimates the US prevalence of OUD to be between 6-7 million people, and the Centers for Disease Control approximates 80,000 opioid overdose deaths annually.

“BRIXADI will serve to be a transformative treatment option in the industry as it serves to treat moderate to severe opioid use disorder. This is a significant step in the fight against opioid misuse, which is a public health crisis in the US and worldwide,” said Pii Vice President of Client Services Devan Patel, who has supported this program from its inception at Pii about 10 years ago. “With this approval and launch, Pii is well positioned to supply both the weekly and monthly product going forward.”

BRIXADI is formulated using Sweden-based Camurus’ FluidCrystal® injection depot technology, licensed by Braeburn. The product is administered subcutaneously by a healthcare professional as a small-volume injection (0.16-0.64 mL) in the buttock, thigh, stomach or upper arm. BRIXADI does not require refrigeration.

John Fowler, President and CEO of Pii, looks forward to bringing BRIXADI to the US market. “OUD is a public health issue in the US exacerbated by a lack of treatment options and inability to access available treatments. We at Pii are pleased to play our part in supporting the availability of BRIXADI as an option to combat the ever-rising issue of OUD.”

About Pii
Pharmaceutics International, Inc. (Pii) is a US-based contract development and manufacturing organization (CDMO) with a passion for solving problems. Pii’s Hunt Valley, Maryland, campus includes 70 manufacturing suites with four integrated aseptic filling lines. We offer contract analytical development and support formulation and manufacturing of oral solid dosage forms. Our professionals have extensive experience with small and large molecule compounds, developing and manufacturing complex parenteral drugs, extended-release formulations, non-aqueous injectable drug products, lyophilization, and DEA-scheduled drugs. Visit pharm-int.com for more information.