London, United Kingdom: The federal regulatory agency that oversees the licensing of prescription medications in the UK announced last week that it requires further clinical evidence of the ability of cannabis extracts to alleviate MS-associated spasticity in a "clinically relevant" manner.
The British firm GW Pharmaceuticals initially submitted a regulatory application for the cannabis extract spray, known as Sativex, in March 2003 after a clinical trial found it to improve spasticity in patients suffering from severe MS, all of whom had previously failed to respond to other available medications. On Friday, the company received notice from the Committee on the Safety of Medicines (CSM), an advisory body of the Medicines and Health products Regulatory Agency (MHRA), suggesting that an additional "confirmatory study" on spasticity would be required before it would decide on whether to approve the licensing of Sativex.
GW Pharmaceuticals stated in a press release that it will appeal the CSM's decision. In parallel, GW also plans to commence the further confirmatory study required by the agency.
The CSM reported that the agency had no outstanding issues with the quality and safety of Sativex.
Several British health organizations, including the MS Society and the Multiple Sclerosis Trust, responded negatively to the CSM's decision to further delay Sativex's approval. The MS Society called the outcome "extremely disappointing," while a spokesperson for the MS Trust told the London Guardian newspaper, "I hope the [CSM] will reconsider their position and give some thought to the impact of this decision on the lives of those with painful, chronic disease."
Previous clinical trials on Sativex have found it to significantly alleviate numerous MS-associated symptoms compared to placebo, including pain, muscle spasms and bladder incontinence. A study appearing in this month's issue of the journal Pain also notes that the extracts significantly reduce neuropathic pain in patients suffering from nerve damage.
The company submitted a regulatory application to Health Canada earlier this year seeking to license the use of Sativex as an analgesic.