EMA CHMP recommends approval of opioid dependence treatment

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/Megan Miks)
(Image: Getty/Megan Miks)

Related tags: Opioid, Opioid epidemic, regulatory

Camrus, a Swedish pharmaceutical company, announced that its drug, Buvidal, has been recommend for approval by the CHMP.

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended approval for Buvidal (buprenorphine) in a prolonged-release solution for injection.

Buvidal was recommended for approval for the treatment of opioid dependence in adults and adolescents over 16 years of age.

According to the World Drug Report​ the global approximate number of individuals using opioids for nonmedical purposes is currently 33 million.

It is administered in weekly and monthly injections by healthcare professionals at clinics developed for the treatment of opioid dependence. The prolonged-release design aims to reduce misuse and provide adherence to the treatment plan.

CHMP based its approval opinion on a comprehensive clinical program with seven clinical studies. One of these studies was a randomized, double-blind, double-dummy, active-controlled Phase III study in 428 participants. All of the participants in the Phase III study had opioid dependence.

The study’s results showed that Buvidal improved treatment outcomes when compared to the standard treatment of sublingual buprenorphine/naloxone.

The drug is currently under regulatory review for approval in the US and Australia. Camurus’ partner Braeburn will be responsible for the regulatory procedure in the US.

The final decision on Buvidal will be decided by the European Commission in late November 2018.

Related news

Show more

Related products

show more

From Candidate to Clinic- European Capabilities

From Candidate to Clinic- European Capabilities

Catalent Pharma Solutions | 22-Oct-2018 | Technical / White Paper

Catalent’s Nottingham, UK facility focuses on early stage development of small molecule drug candidates from the bench to clinic. This facility offers...

Strategies to Select and Deliver the Right Candidate

Strategies to Select and Deliver the Right Candidate

Catalent Pharma Solutions | 05-Mar-2018 | Technical / White Paper

Does your candidate have what it takes to succeed? Do you have the information needed to make the right decisions about your candidate’s path to the clinic?...

Steridose

Optimizing vessel geometry for mag drive agitators

Steridose, Inc | 14-Sep-2017 | Technical / White Paper

The performance of a bottom mount magnetically driven agitator (mag drive mixer) is heavily dependent on its relationship with the vessel’s geometry, baffles,...

Related suppliers

Follow us

Products

View more