Drug name
Last update: Jul 2026Buprenorphine
Developer(s)
Drug information
Buprenorphine
BUVIDAL; BRIXADI
Small molecule
Not provided
1. BUVIDAL is a long-acting injectable based on FluidCrystal platform technology used for opioid dependence. 2. Pharmacokinetic parameters: t1/2 - 19 to 25 days; Volume of distribution - 4300 L. 3. The common adverse events in BUVIDAL-treated patients were injection site pain (8.9%), headache (7.5%), constipation (7.5%), nausea (7%), and injection site pruritus (6%).
BRIXADI is approved in the USA whereas BUVIDAL is approved in European countries, Australia, and New Zealand. United Kingdom and Switzerland. Both brands share the same API, excipient and are marketed under Camurus AB.
Approved by US FDA, EMA, TGA, MHRA, Swissmedic and MedSafe.
Therapeutic area(s)
- Substance use disorders
- Treatment
Administration route
Subcutaneous
Associated long-acting platforms
FluidCrystal technology
Use of drug
- Administered by a community health worker
- Administered by a nurse
- Administered by a specialty health worker
- Weekly
- Monthly
Dosage
• BRIXADI (weekly) is available in 8 mg/0.16 mL, 16 mg/0.32 mL, 24 mg/0.48 mL, and 32 mg/0.64 mL; • BRIXADI (monthly) is available in 64 mg/0.18 mL, 96 mg/0.27 mL, and 128 mg/0.36 mL prefilled syringe
40mg/ week; 160 mg/ month
1. The recommended weekly dose in patients not currently receiving buprenorphine treatment is 24 mg of BRIXADI (weekly) titrated up over the first week of treatment (administer a test dose of transmucosal buprenorphine 4 mg when objective signs of mild to moderate withdrawal appear). 2. If needed, during this first week of treatment, administer an additional 8 mg dose of BRIXADI (weekly), waiting at least 24 hours after the previous injection, for a total weekly dose of 32 mg BRIXADI (weekly). 3. Adults who have tolerated a single 4 mg dose of a transmucosal buprenorphine‐containing product. The test dose of transmucosal buprenorphine‐containing product should be administered based on instructions in the appropriate product label.
The recommended starting dose of Buvidal is 16 mg, with one or two additional 8 mg doses at least 1 day apart, to a target dose of 24 mg or 32 mg during the first treatment week. The recommended dose for the second treatment week is the total dose administered during the week of initiation. The maximum dose per week for patients who are on weekly Buvidal treatment is 32 mg with an additional 8 mg dose. The maximum dose per month for patients who are on monthly Buvidal treatment is 160 mg.
Associated compounds, formulations and regimens
Not provided
Associated technologies
CompareAdditional information
Developer(s)
Camurus
Camurus AB is a biopharmaceutical company that creates long-acting treatments for serious and chronic diseases. This company originated in 1991. Camurus, based on scientific understanding, aims to enhance patient outcomes through innovative therapies. They specialise in pharmaceutical commercialization and have a portfolio that includes clinical trial products as well as two FDA-approved drugs.
Drug structure
Scale-up and manufacturing prospects
In 2022, 830,000 doses were manufactured
Not provided
• Manufacturing and distribution of Camurus’ products is based on a multi-stage supply chain with several participants involved. Braeburn Pharmaceuticals overlooks the manufacturing of the FDA approved drugs of FluidCrystal in liaison with a third party manufacturer. • The manufacturing process includes: - weighing, dissolving, sterile filtration, filling, closing, visual inspection, labelling, assembly in safety device and secondary packaging. The manufacturing process setup aims to reduce product manufacturing waste by 20% and to increase the use of packaging material originating from susta
The listed analytical instrument used was HPLC with UV detection
Excipients & delivery device(s)
No proprietary excipient used
• Glycerol dioleate (a lipid) • Ethanol (as solvent) • Phospholipids
No residual solvent used
No delivery device
Safety, Efficacy and Evidence Summary
Not provided
Not provided
Not provided
Not provided
Depot precursor formulation comprising buprenorphine for sustained delivery of and for treatment of pain or opioid dependence
A depot precursor formulation comprising: a) a controlled-release matrix; b) at least oxygen containing organic solvent; c) at least 12% by weigh of at least one active agent selected from buprenorphine and salts thereof, calculated as buprenorphine free base. Corresponding depot compositions and methods of treatment in pain management, by opioid maintenance and related methods are provided.
WO2014016428
Formulation
Camurus AB
Not provided
July 26, 2033
Granted in: AU, BR, CA, CL, CN, CO, IN, ID, JP, KR, MX, NZ, PE, SG, ZA, TH, US, EA (AM, AZ ,BY, KZ, RU, TJ, TM), EP (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MC, NL, NO, PL, PT, RO, RS, SE, SI, SK, TR) Pending in: AR, IL, MY, HK
FluidCrystal® injection depot technology, and low viscosity, non-liquid crystalline pre-formulation comprising buprenorphine
he present invention relates to compositions forming a low viscosity mixture of: a. at least one diacyl glycerol and/or at least one tocopherol; b. at least one phospholipid component comprising phospholipids having i. polar head groups comprising more than 50% phosphatidyl ethanolamine, and ii. two acyl chains each independently having 16 to 20 carbons wherein at least one acyl chain has at least one unsaturation in the carbon chain, and there are no more than four unsaturations over two carbon chains; c. at least one biocompatible, oxygen containing, low viscosity organic solvent; wherein optionally at least one bioactive agent is dissolved or dispersed in the low viscosity mixture; and wherein the pre-formulation forms, or is capable of forming, at least one non-lamellar liquid crystall
WO2013083460
Formulation
Camurus AB
Not provided
November 28, 2032
Granted: AU, CA, CN, EA (RU), EP (AT, BE, CH, DE, DK, ES, FI, FR, GB, IE, IS, IT, LI, NL, PL, SE, TR), HK, IL, IN, JP, KR, MX, SG, US, ZA Pending: BR, CO, NZ, PE Not in force: EAPO (AM, AZ, BY, KG, KZ, TJ, TM)