First cannabis-based drug approved in Europe

The first cannabis-based pharmaceutical product has been approved in the UK, paving the way for widespread adoption throughout Europe.

The world’s first ever cannabis-based drug, GW Pharmceutical’s Sativex liquid-mouth-spray was first approved in Canada five years ago for the treatment of neuropathic pain associated with spasticity in multiple sclerosis sufferers.

With the UK currently acting as the reference member state, the green light from its Medicines and Healthcare Products Regulatory Agency (MHRA) automatically marks Sativex as eligible for approval throughout other EU countries who chose to accept it. The approval triggered a $US14.8 million payment from GW Pharma’s UK marketing partner Bayer Schering Pharma.

Doctors at Royal Melbourne Hospital are understood to be pushing for a trial of Sativex on MS patients with a view to applying for the drug’s approval with the Therapeutic Goods Administration. Under the TGA’s ‘special access scheme’, it is however possible for Australian doctors to receive approval for the use of Sativex in certain cases, with a Melbourne specialist understood to have recently administered the drug to treat a rare neurological condition.

Industry analysts Datamonitor estimate that Sativex will generate around $28 million in sales over the next ten years in Europe. However, according to Datamonitor analyst Trung Huynh negative attitudes towards cannabis in the U.S will make it difficult for the drug to gain approval there. He also observes that there appears to be some sort of novelty value associated with Sativex being cannabis-derived, noting that several other treatments on the markets in Europe and the U.S have equal or better benefits for lower costs.

“The novelty is that it is the first approved cannabis medication [ in Europe ],” Huynh said.

“However, is it going to change the world of symptomatic multiple sclerosis?”

“I’m afraid the answer is no.”

All up Sativex is expected to cost around 11 pounds a day in the UK, but will typically only be prescribed in conjunction with existing MS treatments which can cost anywhere up to $30,000 a year.

Beyond the MS market, GW Pharma is hoping to establish Sativex as an approved treatment for the cancer pain market, and has already advanced into Phase III trials following promising Phase IIb results.