Can a Cannabis-based Drug Gain Approval in the U.S.?

While there is increasing acceptance of the idea of cannabis-based drugs and the use of marijuana for medicinal purposes (particularly in California), there is still political resistance across much of the U.S. Britain's GW Pharma continues to push ahead with Sativex, which was approved in Canada five years ago for neuropathic pain associated with MS. MHRA has now also approved its use related to spasticity in MS patients (see press release in italics below).

Whatever your political predilections, you may be interested in how the cannabis is grown, controlled, and used for manufacturing. When I interviewed GW Pharma's Mark Rogerson five years ago, the company was just beginning to consider seeking approval in the U.S. It's interesting to note that, in 2010, it has made some progress and, with Otsuka Pharmaceuticals, is in Phase III trials in the U.S. for an indication to treat pain associated with cancer.

--Paul Thomas

Press Release: June 21, 2010:
Coming 5 years after the Canadian regulatory approval for neuropathic pain associated with multiple sclerosis, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted GW Pharma a license to launch Sativex for the treatment of spasticity in patients with multiple sclerosis.
 
Utilizing the European decentralised procedure with the UK acting as the Reference Member State, Sativex’s approval signals a major landmark for the acceptance of cannabis based drugs. However, Sativex’s commercial success will now hinge on future recommendations by European health advisory agencies and overcoming significant political hurdles in the US.
 
GW Pharma has indicated Sativex will be made available at around $16 per day, translating into a yearly cost of nearly $6,000 in the UK. Given Sativex will be prescribed in conjunction with available MS disease-modifying therapies which already carry a high price premium of between $15,000 and $30,000, the key for Sativex’s UK success will be to convince the National Institute for Health and Clinical Excellence (NICE) that it is cost-effective .
 
Sativex is marketed by Bayer Schering Pharma in Canada and the UK. In 2005, Sativex, became the world’s first commercially available cannabis-derived medicinal product when approved in Canada for neuropathic pain in multiple sclerosis. Prior to UK approval, Sativex was available in the UK and Spain as an unlicensed medicinal product, which permits physicians to prescribe to select patients whom they consider may benefit. Moreover, in addition to seeking approval in neuropathic pain and multiple sclerosis spasticity, Sativex was recently advanced into Phase III trials in cancer pain following positive Phase IIb results. GW Pharma has also announced its intentions to pursue this as the primary indication with Otsuka Pharmaceutical in the US.
 
Datamonitor believes Sativex’s true value lies in GW Pharma’s ability to obtain approval in the US for the more lucrative indication of cancer pain. However, a substantial political hurdle exists, with the US government imposing strict guidelines on medicinal cannabis use and as yet has only approved a synthetic version, Marinol (dronabinol). Regardless of permission from the US regulatory authority, the FDA, to initiate late stage trials, unless the US government’s stance changes, it is unlikely Sativex will gain approval anytime soon.
 
Although approval as the first cannabis-derived agent in Europe is a positive sign, Sativex’s patient population faces potential restrictions over reimbursement and US regulatory approval. There is also the critical question of whether physicians will accept and embrace Sativex due to the widespread stigma associated with cannabis products. As such Datamonitor forecasts the five major European market sales in multiple sclerosis to reach only $28m by 2019.

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