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U.S.: Sativex Gets Fast Track Designation From FDA For Cancer Pain

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By Steve Elliott
Hemp News

Big Pharma continues its moves to take over the medical marijuana industry. GW Pharmaceuticals, a biopharmaceutical company based in the United Kingdom, on Monday announced the the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Sativex, an oral spray containing THC and CBD in a 50:50 ratio, for the treatment of pain in patients with advanced cancer.

Sativex is currently in Phase 3 clinical trials for this indication, according to a press release from GW Pharmaceuticals.

The FDA's Fast Track program facilitates the developmental process for drugs intended to treat serious or life-threatening conditions and that have the potential to address "unmet medical needs." A drug program with Fast Track status is given greater access to the FDA for the purpose of speeding up the drug's development, review and potential approval.

"The award of Fast Track designation for Sativex represents important recognition by the FDA of the potential of this medicine to address significant unmet needs in the treatment of cancer pain," said Justin Gover, CEO at GW Pharmaceuticals. "Sativex is the only non-opioid treatment currently in Phase 3 development for patients who do not respond to, or experience negative side effects with opioid medications.

"We are fully committed to delivering the first FDA-approved cannabinoid medicine for these patients who currently have nowhere else to turn," Gover said.

GW is developing Sativex in the U.S. in collaboration with Otsuka Pharmaceutical Co., Ltd.

France: GW Pharmaceuticals Applies To Expand Sativex Approval

GWPharmaceuticalsCannabisSativa

By Steve Elliott
Hemp News

Big Pharma giant GW Pharmaceuticals has submitted an application seeking to expand marketing authorization for Sativex into France for the treatment of spasticity due to multiple sclerosis (MS).

Sativex, an oral spray containing a 50:50 mixture of the cannabinoids THC (tetrahydrocannabinol) and CBD (cannabidiol), is already approved as a treatment for MS spasticity in 21 countries, including 17 countries in Europe. The medicine is available on prescription in the United Kingdom, Spain, Germany, Canada, Denmark, Norway, Israel, Austria, Poland, Sweden and Italy, with launches in preparation in eight more European countries, as well as Australia and New Zealand, according to GW.

"Sativex meets a significant unmet medical need for patients with multiple sclerosis and we look forward to working with the French authorities so as to allow this important medicine to be made available in France," said Justin Gover, chief executive officer at GW Pharmaceuticals.

"The submission of this MRP for Sativex in France builds on the recent commercial launch in Italy and continues the momentum of expanding Sativex availability throughout Europe," Gover said. "We see this growth as important validation of patient and physician acceptance of Sativex in meeting the needs of people with multiple sclerosis."

GW Pharmaceuticals Announces Sativex® Now Available In Italy

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By Steve Elliott
Hemp News

Sativex, the 50:50 combination of THC (tetrahydrocannabinol) and CBD (cannabidiol) in oral spray form, made by GW Pharmaceuticals, is now available in Italy, GW's partner company Almirall announced on Monday.

Sativex is available in Italy as a prescription medicine for treatment of moderate to severe spasticity in multiple sclerosis (MS) patients who have not responded to other anti-spasticity medicines. The launch follows full marketing authorization for Sativex by Italian health authorities in May.

The medication is reimbursed by Italian authorities as a Class H (hospital dispensed) medicine. The reimbursed price of Sativex granted by government authorities in Italy is consistent with the reimbursed price of Sativex in Spain, according to GW.

"As one of the largest markets in Europe, the launch of Sativex in Italy is a key milestone in the commercialization of this important new medicine," said Justin Gover, chief executive officer of GW. "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.

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