The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of naloxone nasal spray (Nyxoid) for the treatment of opioid overdose and buprenorphine plus naloxone sublingual tablets (Zubsolv) for the treatment of opioid dependence. Both products are made by Mundipharma Corporation Limited.
Nyxoid, which reverses symptoms of opioid overdose, will be available as a nasal spray (1.8 mg). The most common side effects are nausea and opioid withdrawal syndrome, the EMA said in a news release. Nyxoid is a hybrid medicine of naloxone HCl (solution for injection), which has been authorized in the European Union since 2006.
Nyxoid is intended for immediate administration as emergency therapy for known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in both nonmedical and healthcare settings. Nyxoid is indicated in adults and adolescents aged 14 years and older. It is not a substitute for emergency medical care, the EMA says.
Zubsolv for opioid dependence will be available as tablets for sublingual use in the following doses: 0.7 mg/0.18 mg, 1.4 mg/0.36 mg, 2.9 mg/0.71 mg, 5.7 mg/1.4 mg, 8.6 mg/2.1 mg, and 11.4 mg/2.9 mg.
Zubsolv is indicated as “substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction,” the EMA says.
The most common side effects with Zubsolv are constipation, nausea, insomnia, and headache. Zubsolv should be prescribed by physicians experienced in the treatment of opioid dependence, the EMA says.
Further recommendations and details for both products will be published in their European public assessment report after the European Commission grants full marketing authorization.
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