CHMP positive for Buprenorphine Neuraxpharm (buprenorphine) to treat opioid dependence
The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Buprenorphine Neuraxpharm, intended for the substitution treatment of opioid dependence.The applicant for this medicinal product is Neuraxpharm Pharmaceuticals S.L
Buprenorphine Neuraxpharm will be available as 0.4 mg, 4 mg, 6 mg and 8 mg sublingual films. The active substance of Buprenorphine Neuraxpharm is buprenorphine, a drug used in opioid dependence (ATC code: N07BC01). Buprenorphine is a partial opioid agonist/antagonist. The benefit with buprenorphine Neuraxpharm is that it can be used as a substitute for opioids during addiction treatment. The most common side effects with buprenorphine Neuraxpharm are headache, nausea, hyperhidrosis, insomnia, abdominal pain, drug withdrawal syndrome.
Buprenorphine Neuraxpharm is a hybrid medicine of Subutex, which has been authorised in the EU since 1995. Buprenorphine Neuraxpharm contains the same active substance as Subutex, but the formulation differs. Buprenorphine Neuraxpharm will be available as sublingual films, whereas Subutex is available as a prolonged-release solution for injection or as sublingual tablets.
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