Cannabis-based spray approved in Italy

GW Pharmaceuticals, a UK-based company, announced a key victory in Europe early this morning.

Outlined in a press release, it appears that Sativex, GW Pharmaceutical's patented oral spray, has been granted full marketing authorization by regulatory bodies in Italy for the treatment of spasticity in multiple sclerosis.
According to CEO Justin Grover, this brings the total to 21 countries that have approved Sativex for use in the treatment of MS-related spasticity.
A commercial launch in Italy is expected for September by GW Pharmaceuticals' distribution partner, Almirall S.A. The Sativex manufacturers received a €250,000 milestone payment from Almirall following the announcement.
In 2005, Canada became the first country to approve Sativex, which GW Pharmaceuticals received before the drug was even approved in its home country.
While cannabis-based pharmaceuticals have been available since 1985, GW Pharmaceuticals took a unique approach in developing Sativex by using ingredients derived from the marijuana plant itself, namely tetrahydrocannabinol (THC) and cannabidiol (CBD).
Other treatments, such as Marinol and Cesamet, depend on synthetic isomers of THC, which seem easier to market in the United States. Likewise, Sativex has yet to receive FDA approval, although GW Pharmaceuticals hopes to enter the U.S. market by the end of 2013.
Sativex contains a standardized, near 1:1 ratio of THC and CBD - two of the most medically researched compounds of marijuana. It also utilizes a novel delivery method, with the compounds being absorbed through the oral mucosal lining of the mouth.
The spray has been clinically trialed for a variety of indications, including multiple sclerosis, cancer pain, neuropathic pain and arthritis.
Although Sativex is touted as a safer method of cannabis-based treatment, the drug has been shown to elicit many of the same side-effects as medical marijuana, including euphoria, dizziness and fatigue.
Still, Sativex continues to surpass medical marijuana in gaining regulatory approval, which has helped GW Pharmaceuticals to establish distribution partnerships with some very large companies, such as Bayer and Novartis.

http://www.digitaljournal.com 7/5/2013