---<br /> A cannabis-based medicine which had excited the hopes of many multiple <br /> sclerosis patients has been refused a licence.<br /> <br /> Many people with the devastating disease have used cannabis illicitly to <br /> relieve the symptoms, such as spasticity and nerve pain, so there had been <br /> great expectations of the medicine, produced as a nasal spray called <br /> Sativex, which had been undergoing trials for several years.<br /> <br /> But the Medicines and Healthcare Products Regulatory Authority announced <br /> that the licence application to treat spasticity filed by GW <br /> Pharmaceuticals, which designed and manufactured the drug, had been turned <br /> down on appeal. The MHRA said there was not enough proof that the drug worked.<br /> <br /> "We acknowledge that this decision may cause disappointment to MS patients. <br /> However, there was insufficient evidence to show that the risk-benefit <br /> relationship was favourable," said Kent Woods, the authority's chief executive.<br /> <br /> Patient groups were dismayed and the company's chairman, Geoffrey Guy, said <br /> he was "very, very frustrated". He said further trials were under way to <br /> try to obtain the data that would convince the regulator to grant a licence.<br /> <br /> The MHRA is satisfied that the drug is safe and of good quality - but it <br /> has fallen at the third hurdle, efficacy.<br /> <br /> Dr Guy said his company had won the battle to have patients' reports of <br /> their improvement considered, rather than an assessment of how much better <br /> they were on a disputed clinical scale. But another trial must now be run <br /> to obtain data from larger numbers of patients.<br /> <br /> Mike O'Donovan, chief executive of the Multiple Sclerosis Society, said: <br /> "This news will be greeted with dismay by many of the 85,000 people in the <br /> UK who have MS and suffer from distressing symptoms, including spasticity <br /> and pain. How long must they wait? When the society spoke at the Medicines <br /> Commission hearing we stressed that the choice of available treatments was <br /> limited, and many people did not find them effective. It was emphasised <br /> that measurements to assess new treatments for a fluctuating condition like <br /> MS do not always detect significant benefits patients feel.<br /> <br /> "We believe there is convincing evidence that cannabis-derived drugs can <br /> significantly improve their quality of life."<br /> <br /> Christine Jones, chief executive of the MS Trust, agreed. "It is extremely <br /> frustrating that the prospect of a licensed cannabis-derived medicine is <br /> still no closer," she said.<br /> <br /> "Unfortunately neither the Medicines Commission nor the MHRA appears to be <br /> willing to take account of the very positive and statistically significant <br /> feedback from people with MS, who report relief from spasticity."<br /> <br /> Sativex has already been given a licence for nerve pain relief in Canada, <br /> although this was conditional on more trials being done. Dr Guy said the <br /> company had a lot of evidence that the drug was effective in pain relief - <br /> but was told to apply for a licence for spasticity by the MHRA, only to be <br /> told that the efficacy data was not sufficient.<br /> <br /> He said the drug was very helpful to some people in the trials. "The <br /> investigators see some patients' lives being totally changed beyond <br /> recognition," he said. "There are no other medicines that treat these <br /> patients. All our work was done in patients for whom all other treatment <br /> possibilities had been exhausted."<br /> <br /> There are 400 patients in the UK still taking Sativex because they were in <br /> the trials. Other patients may seek to get it from Canada, he said, but <br /> they will need a prescription from a doctor who believes the drug can help, <br /> approval from the MHRA, and an import licence from the Home Office, because <br /> cannabis is a schedule 1 drug.<br /> <br /> Dr Guy said he would now push for cannabis to be rescheduled, because <br /> therewas proof that it had a medical use, both from Canada and from the UK <br /> trials. 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