Almirall has launched its cannabinoid treatment Sativex for moderate to severe spasticity in multiple sclerosis (MS) patients in Italy.
The drug, developed by GW Pharmaceuticals, was approved by Italian authorities in May and comes to the market with a reimbursed priced that GW said was “consistent with the reimbursed … price in Spain”.
Sativex (nabiximols) is licensed to treat moderate to severe spasticity in MS patients who have not responded adequately to other anti-spasticity medication and will be reimbursed by the Italian authorities as a Class H (hospital dispensed) medicine.
It makes Sativex, which is administered as an oromucosal spray, the first medicine containing cannabinoids to be made available in Italy for the treatment of spasticity in MS.
Justin Gover, GW’s CEO, said: “As one of the largest markets in Europe, the launch of Sativex in Italy is a key milestone in the commercialisation of this important new medicine. Italy represents yet another addition to the growing number of countries in Europe in which Sativex is now available to treat MS spasticity, a particularly debilitating symptom of MS that is not adequately treated with currently available medications.
“With a total of 21 countries that have now approved Sativex for use in the treatment of MS spasticity, and a further nine countries in which regulatory submissions are ongoing, we look forward to a series of further commercial launches over the coming twelve months.”
The drug contains cannabinoids extracted from cannabis sativa plants grown and processed under strictly controlled conditions. It is comprised of two primary active components, THC (delta-9-tetrahidrocannabinol) and CBD (cannabidiol).
GW said that in order to monitor therapeutic accuracy and appropriateness, a National Register has been established in which patients in Italy who are treated with Sativex will be enrolled.
Sativex has been given a rolling launch in Europe, with GW partnering with Bayer in the UK and non-European markets. The company has also signed deals with Novartis and Otsuka.