CHMP recommends buprenorphine implant for opioid dependence

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Sixmo, a buprenorphine implant for the management of opioid dependence.

Sixmo consists of four small rods containing 74.2mg buprenorphine that are implanted subcutaneously in the patient’s upper arm under local anaesthetic, which continuously deliver the drug over six months. The aim of this mode of administration is to enhance adherence to treatment and reduce the potential for misuse or accidental overdose.

If marketing authorisation is granted by the EC, Sixmo will be indicated for substitution treatment for opioid dependence in clinically stable adults who require no more than 8mg daily sublingual buprenorphine, within a framework of medical, social and psychological treatment.

In a pivotal clinical trial that enrolled 177 adults with opioid use disorder who were considered clinically stable, 96.4% of patients given Sixmo responded to treatment compared with 87.6% treated with sublingual buprenorphine (p<0.001 for non-inferiority). The most common adverse effects were headache, constipation and insomnia; known side-effects of the active substance buprenorphine. The most common adverse effects relating to the administration of the product were pain, severe itching and haematoma at the implant site. The manufacturer has been instructed to perform an additional study to evaluate the risks associated with insertion and removal of the implants.

Back in February, another long-acting buprenorphine formulation, Buvidal, was launched in the UK. Buvidal is a prolonged-release sucutaneous depot injection that is available in various strengths for either weekly or monthly administration to allow treatment to be individualised to specific patient needs. Buvidal is indicated for the treatment of opioid dependence in adults and adolescents aged 16 years or over within a framework of medical, social and psychological treatment.

 

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