Date: 2017-11-10
Type of information: Granting of a Market Authorisation in the EU
Product name: Zubsolv®
Compound: buprenorphine and naloxone sublingual tablet
Therapeutic area: CNS diseases
Action mechanism:
- opioid agonist/opioid receptor antagonist. Buprenorphine and naloxone are used in addictive disorders and act as opioid agonist and opioid receptor antagonist, respectively.
Company: Mundipharma (UK) Orexo (Sweden)
Disease: opioid dependence
Latest news:
- • On September 14, 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Zubsolv® (buprenorphine/naloxone) intended for the treatment of opioid dependence. Zubsolv® will be available as tablets for sublingual use (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).
The most common side effects are constipation, nausea, insomnia and headache. The full indication is: "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."
- Mundipharma and Orexo have worked collaboratively in completing the submission. This was based on data from a bioequivalence study, previous pharmacokinetic studies, and Orexo’s extensive clinical program that includes data on more than 1,000 opioid dependent patients.
- Under the terms of a 2016 agreement with Mundipharma, Orexo will receive a milestone payment pending achievement of an EU marketing authorization and commercialisation of Zubsolv. Orexo are also entitled to receive further milestone payments as well as tiered royalties on future net sales.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2017-11-10
Favourable opinion UE: 2017-09-14
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
