GW's cannabis-based mouth spray gains Austrian OK for MS spasms
British drug developer GW Pharmaceutical will debut its cannabis-based pain therapy Sativex in Austria as a treatment for MS-related spasticity sometime in 2012, following regulatory approval announced Feb. 7.
The drug is delivered by way of an oromucosal (mouth) spray. Plans call for launching the drug commercially after the company completes the national pricing and reimbursement process. Marketing partner Almirall will sell Sativex.
The drug is the first marijuana-based treatment made by extracting cannabinoids directly from the cannabis plant rather than making them synthetically, according to a MyHealthNewsDaily story analyzing the drug's U.S. approval prospects running on FoxNews.com. THC is a key ingredient, which helps make marijuana smokers feel high. But the drug isn't as likely to be abused because it is ingested through a mouth spray rather than smoked, experts noted in the story, which delays its effect. Patients can also adjust the dose so it enters the blood gradually and relieves symptoms without getting high, GW Pharmaceuticals is quoted as saying.
In the U.S., the drug is in Phase III clinical development to treat cancer pain. The story notes that GW Pharmaceuticals plans to seek FDA approval once trials are finished in 2014.
Austria became the seventh country in which Sativex has gained approval as a prescription drug. The United Kingdom, Spain, Germany, Denmark, Canada and New Zealand have approved the drug for prescription use. Regulatory review is pending in Belgium, Finland, Iceland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia.