New doubts over cannabis-based drug knocks confidence in GW Pharma

GW Pharmaceuticals, the drug development company trying to launch Britain's first cannabis-based painkiller, has moved to head off a new blow to its reputation, after speculation that it has lost its appeal to allow its drug on the market without additional tests.

GW Pharmaceuticals, the drug development company trying to launch Britain's first cannabis-based painkiller, has moved to head off a new blow to its reputation, after speculation that it has lost its appeal to allow its drug on the market without additional tests.

GW said it had not yet heard back from the UK's medicines regulator, the MHRA, despite a report citing government sources that the appeal had been rejected.

The regulator told GW in December that it had not proved its under-the-tongue spray, Sativex, was useful as a treatment for multiple sclerosis.

Although GW believes the drug relieves spasticity, the MHRA was uncertain that this represented a significant improvement in the quality of life of MS sufferers. Yesterday, the online medical news agency Agence de Presse Medical said the MHRA's advisory body, the Medicines Commission, had heard an appeal by the company two weeks ago and rejected its case.

GW, whose shares fell 25 per cent when the MHRA demanded more trials in December, rushed out a statement after the stock market close yesterday. It said: "The company confirms that this appeal was considered by the Medicines Commission at its meeting in mid-May.

"GW is yet to be informed of any recommendations made by the commission to the MHRA, nor has it received any communication from the MHRA since the meeting."

The MHRA refused to comment, and it is believed that formal notification of the decision could take another couple of weeks.

GW, led by its executive chairman, Dr Geoffrey Guy, has received conditional approval to launch Sativex in Canada, where cannabis is already available for medical use. It has already started the extra trials demanded by the MHRA, but these will take until the end of the year to complete, delaying Sativex's UK launch into 2006 at the earliest.