EMA OKs Sublingual Formulation for Opioid Dependence

The European Medicines Agency has recommended granting marketing authorization for a new hybrid formulation of buprenorphine as a substitution treatment of opioid drug dependence. Buprenorphine Neuraxpharm is available as multiple-strength sublingual films.

The Committee for Medicinal Products for Human Use (CHMP) said its recommendation was intended to cover use in adults and adolescents 15 years of age or older who had agreed to be treated for addiction. The drug should be used within a comprehensive therapeutic monitoring framework of medical, social, and psychological treatment.

New Hybrid of Long-Approved Medication

A hybrid medicine is similar to an authorized medicine containing the same active substance but has certain differences, such as in strength, indication, or pharmaceutical form. 

Buprenorphine Neuraxpharm is a hybrid medicine of Subutex, a formulation of buprenorphine hydrochloride manufactured by Indivior UK Limited and available as 0.4 mg, 2 mg, and 8 mg sublingual tablets or as a prolonged-release solution for injection. Subutex has been authorized in the European Union since 1995.

Neuraxpharm Pharmaceuticals S.L. submitted a hybrid application for the sublingual film product, relying in part on the results of preclinical tests and clinical trials of the already authorized reference product, and in part on new data.

The CHMP said that buprenorphine is a partial opioid agonist/antagonist and can be used as a substitute for opioids during addiction treatment. Buprenorphine Neuraxpharm is subject to special and restricted medical prescription. Treatment should be prescribed and supervised by a doctor experienced in the management of opiate dependence/addiction. 

The most common side effects with the new formulation are headache, nausea, hyperhidrosis, insomnia, abdominal pain, and drug withdrawal syndrome, which are similar to adverse effects of Subutex.

Buprenorphine Neuraxpharm will be available as 0.4 mg, 4 mg, 6 mg, and 8 mg sublingual films. Full recommendations will be described in the summary of product characteristics, which will be published after marketing authorization has been granted by the European Commission.