BUVIDAL (buprenorphine)

Key points

Favourable opinion for reimbursement in the treatment of opioid dependence within a framework of medical, social and psychological treatment in adults and adolescents aged 16 years or over.

What therapeutic improvement?

Therapeutic improvement compared to sublingual buprenorphine/naloxone.

Role in the care pathway?

Opioid replacement therapy should be part of an overall process of support, medical, psychological, social and educational follow-up and rehabilitation of the dependent person, aspects that require networking and a collaborative approach between facilities. The success of medicinal treatments depends largely on the quality of the psychotherapeutic and social support provided.

Two sublingual or oral medicinal products with an MA in the treatment of opioid dependence are currently prescribed:

• high-dose buprenorphine (HDB) alone or in combination (HDB/naloxone), included in list I with prescribing and dispensing rules for narcotics, which may be prescribed by any physician;
• methadone, classed as a narcotic, for which initial prescription is reserved for physicians practising in addiction prevention and support and treatment centres (CSAPA), in a hospital department or in a prison healthcare unit.

Role of the medicinal product in the care pathway:

BUVIDAL (buprenorphine), prolonged-release solution for injection is an additional therapeutic option in the medicinal treatment of opioid dependence in adults and adolescents aged 16 years or over. The prescription of BUVIDAL (buprenorphine in prolonged-release form) is reserved for physicians practising in an addiction prevention and support and treatment centre (CSAPA), or for hospital physicians. The weekly or monthly administration of injections (hospital or addiction treatment centre) must be carried out by a healthcare professional.

The available clinical data suggests that the therapeutic contribution of BUVIDAL (buprenorphine in prolonged-release form) compared to sublingual buprenorphine/naloxone depends on the patient’s drug using profile (main opioid substances used, use by injection). The role of BUVIDAL in the care pathway remains to be specified. It will depend, in particular, on the patient’s acceptance of the rules inherent to this treatment.