Date: 2018-09-20
Type of information: Positive opinion for the granting of a Market Authorisation in the EU
Product name: Buvidal® (CAM2038)
Compound: buprenorphine
Therapeutic area: CNS diseases
Action mechanism:
- opioid agonist/antagonist. Buprenorphine is used in addictive disorders and act as an opioid partial agonist/antagonist.
- CAM2038 weekly and monthly buprenorphine injection depots have been developed for the treatment of opioid dependence within a framework of medical, social and psychological treatment. CAM2038 is designed for flexible weekly and monthly dosing, allowing tailored treatment to the patient’s individual needs. CAM2038 will be administered by healthcare professionals, which is expected to increase treatment adherence, while potentially minimizing the risks of diversion, misuse, overdoses and accidental exposure to children and teenagers.
- CAM2038 has been successfully evaluated in a comprehensive clinical program comprising five Phase 1 and 2 clinical studies, as well as Phase 3 pivotal efficacy and long-term safety studies including both new-to-treatment patients as well as patients switched from sublingual buprenorphine products.
- Formulated with Camurus’ FluidCrystal® injection depot technology, CAM2038 is presented ready for use in pre-filled syringes for weekly or monthly administration by a healthcare professional as small dose volume subcutaneous injection through a thin, 23-gauge needle. CAM2038 is developed for room temperature storage, avoiding the need for cold chain distribution and refrigerator storage. Therefore, no mixing steps or room temperature conditioning are required prior to administration.
- The drug is currently under regulatory review for approval in the US and Australia. Camurus’ partner Braeburn is the sponsor for the regulatory procedure in the US.
Company: Camurus (Sweden)
Disease: opioid dependence
Latest news:
- On September 20, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Buvidal®, intended for the treatment of opioid dependence. The drug will be available as a prolonged-release solution for injection (8, 16, 24, 32, 64, 96 and 128 mg). Buvidal can substitute for opioids during addiction treatment. The most common side effects are headache, nausea, hyperhidrosis and insomnia.
- Buvidal® is a hybrid medicine of Subutex®, which has been authorised in the EU since 1998. Buvidal® contains the same active substance as Subutex®, but differs in strength and route of delivery. The full indication is: “Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.”
- The CHMP positive opinion for Buvidal® is based on a comprehensive clinical program with seven clinical studies, including a randomized, double-blind, double-dummy, active controlled Phase 3 study in 428 patients with opioid dependence. Results from this study demonstrated that Buvidal® provided improved treatment outcomes compared to daily standard treatment with sublingual buprenorphine/naloxone.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE: 2018-09-20
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
