Bayer launches world’s first cannabis-derived prescription drug
pharmafile | June 21, 2010 | News story | Sales and Marketing | Bayer, GW Pharmaceuticals, Sativex
Bayer Healthcare has launched the world’s first cannabis-derived prescription drug in the UK.
Sativex treats the spasticity symptoms of multiple sclerosis, such as spasms and cramps, and is manufactured with government permission at a secret UK location.
It is the first cannabinoid medicine to be derived from whole plant extracts of the cannabis sativa plant and contain both delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
Professor John Zajicek, a neurology consultant at Derriford Hospital in Plymouth, said Sativex’s launch was a milestone for cannabinoid medicines.
“Current standard therapy for MS-associated spasticity can produce side effects which patients may find difficult to cope with and not all of them are specifically licensed for spasticity.
“Sativex on the other hand has mainly mild to moderate side effects, which can be easily controlled by adjusting the dose. It has really benefited those people who have found it effective and is a useful addition to available treatments.”
Some 84% of MS sufferers are affected by spasticity, which is caused by damage to those nerves in the central nervous system that carry messages instructing muscles how to move, leading to involuntary muscle over-activity.
Sativex is licensed as an add-on treatment for symptom improvement in patients with moderate to severe spasticity due to MS who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy.
It is only available on prescription from a physician with experience in treating MS spasticity and administered by a spray onto the inside of the cheek or under the tongue.
The patient decides how many sprays they need in any one day, with a typical patient taking eight sprays a day from a daily limit of up to 12 sprays.
Sativex’s troubled route to market
The drug has endured years of delays as its developer and manufacturer, GW Pharmaceuticals, struggled to demonstrate efficacy to regulators after initially eyeing a 2003 approval date.
But last year a phase III study of nearly 600 patients comparing Sativex against placebo showed a highly statistically significant change in spasticity severity for GW Pharmaceutical’s drug, paving the way for its UK approval.
Dr Geoffrey Guy, GW’s chairman, said: “GW was founded with the primary goal of developing a medicine to address the unmet needs of people with MS and today’s launch of Sativex represents a welcome advance in MS symptom treatment.
“This is also an historic moment for GW and marks the beginning of the company’s transition from late stage development company to a commercial pharmaceutical business. Today’s news validates our cannabinoid technology platform and enables us to progress the development of our pipeline across a range of therapeutic areas with increased confidence.”
Under the terms of the company’s agreement with Bayer, GW will receive a £10 million milestone payment in respect of the UK approval of Sativex.
Elsewhere in Europe the drug will be marketed by Laboratorios Almirall, with the company’s home market of Spain expected to approve Sativex for its first mainland European launch shortly.
Further submissions will then be made in additional European countries during the second half of 2010 under the mutual recognition procedure.
Dominic Tyer
Related Content
Evotec and Bayer announce new kidney disease study
Evotec and Bayer have announced the initiation of a phase 2 clinical study in kidney …
Third application for Orion’s prostate cancer drug submitted by partner Bayer
Finnish pharmaceutical company Orion has announced that its partner Bayer is applying for a third application …
Bayer and Evotec to collaborate on precision cardiology
Bayer and Evotec have announced that they have updated the focus of their collaboration to …
