The European Medicines Agency accepts application to extend the Buvidal indication to include treatment of chronic pain

Camurus (NASDAQ STO: CAMX) today announces that the European Medicines Agency (EMA) has accepted the company’s submission of a Type II variation application for Buvidal (buprenorphine) prolonged release injection to include treatment of chronic pain.

“We are pleased that the review procedure has been initiated. There is a high unmet medical need in chronic pain, particularly among patients with concomitant opioid use problems. If approved, Buvidal could become an important therapeutic option for the management of chronic pain, adding to the current indication of treating opioid dependence”, says Dr. Fredrik Tiberg, CEO and Head of R&D at Camurus. “Buvidal is administered by health care professionals as weekly or monthly subcutaneous injections and therefore reduces the risks of misuse and diversion and may further improve adherence and compliance compared with daily treatments.”

Chronic pain is estimated to affect over 20% of the European population^1,2, with an even higher prevalence rate of 33-55% amongst patients diagnosed with opioid dependence.^3,4 Management of the condition is today regarded as one of the most difficult clinical challenges.^5,6 Opioids have for long been used in the treatment of chronic pain for achieving and maintaining an optimal level of pain control. However, long-term opioid therapy is associated with increased risks of developing dependence and misuse.^5,7

The regulatory submission is supported by results from a Phase 2 study of Buvidal (CAM2038) in patients with chronic non-cancer pain and opioid dependence, and a Phase 3 efficacy and safety study of CAM2038 in patients with moderate to severe chronic low back pain treated with opioid pain medications for a minimum of 3 months prior to study enrollment. The Phase 3 study also comprised an open-label extension phase over 52 weeks, assessing long-term efficacy and safety in roll-over patients from the randomized part of the study and new patients with different categories of moderate to severe, chronic non-cancer pain. Both primary and secondary endpoints were met in the randomized part of the study, demonstrating significantly lower average and worst pain scores for patients treated with CAM2038 compared to placebo at the end of the randomized treatment period compared to baseline. The safety profile was consistent with both the well-known profile of buprenorphine, and with the safety profile of Buvidal in opioid dependent patients.