International Approvals: Sativex, Travatan Z, Eslax

Yael Waknine

August 20, 2007

August 20, 2007 — Health Canada has approved a new indication for a cannabis-derived buccal spray, allowing its use as adjunctive treatment for pain in patients with advanced cancer not responding adequately to strong opioid therapy. Japan has approved a benzalkonium chloride-free formulation of travoprost 0.004% ophthalmic solution for the treatment of glaucoma and ocular hypertension, as well as a rocuronium bromide injection for use during general anesthesia.

Cannabis-Derived Buccal Spray ( Sativex) for Opioid-Resistant Cancer Pain in Canada

On August 7, Health Canada approved a new indication for a cannabis-derived pharmaceutical buccal spray (Sativex, GW Pharmaceuticals, PLC, and marketed by Bayer, Inc [a subsidiary of Bayer AG]) for adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain.

According to a joint company news release, the approval was granted under the Notice of Compliance with conditions policy, which reflects the promising nature of the clinical evidence, which will be confirmed with further studies.

The spray is composed primarily of delta-9-tetrahydrocannabinol (Tetranabinex) and cannabidiol (Nabidiolex), a nonpsychoactive cannabinoid. Both are extracts of chemically and genetically characterized Cannabinis sativa L. plants and are delivered in a 2.7-mg/25-mg ratio, with each application being under the tongue or on the inside of the cheek.

Although the mechanism of action is unclear, the product is thought to exert its action by acting on cannabinoid receptors distributed throughout the central nervous system and in immune cells.

The approval was based on data from a double-blind parallel group study, showing that addition of the cannabis-based treatment to existing opioid and other analgesic medication significantly improved pain relief relative to placebo in patients with cancer pain not responding adequately to strong opioids. Furthermore, more than 40% of patients were able to achieve a clinically important reduction in pain.

In clinical trials, the most commonly observed adverse events included nausea, fatigue, dizziness, and application site reactions. These events were usually mild or moderate in severity and often resolved with down-titration or interruption of treatment.

The cannabis-derived product previously was approved by Health Canada for the adjunctive treatment for the symptomatic relief of neuropathic pain in multiple sclerosis in adults. It has not been approved by the US Food and Drug Administration.

BAC-Free Travoprost Ophthalmic Solution (Travatan Z) for Glaucoma, Ocular Hypertension in Japan

On July 31, the Japanese Ministry of Health, Labor, and Welfare approved travoprost 0.004% ophthalmic solution (Travatan Z, Alcon, Inc) for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are intolerant of or insufficiently responsive to other IOP-lowering medications. The product differs from the previously approved travoprost 0.004% solution (Travatan) in that benzalkonium chloride (BAC) has been replaced with an ionic buffered preservative system that is gentler to the ocular surface. According to a company news release, long-term use of topical solutions containing BAC may compromise the ocular surface and exacerbate conditions such as dry eye.

Travoprost 0.004% BAC-free ophthalmic solution previously was approved by the US Food and Drug Administration in September 2006.

Rocuronium Bromide Injection ( Eslax) for General Anesthesia in Japan

On August 1, the Japanese Ministryof Health, Labor, and Welfare approved the neuromuscular blocking agent rocuronium bromide (Eslax, Nippon Organon [an affiliate of Organon, Inc]) for use during general anesthesia.

The agent has a rapid to intermediate onset depending on dose and intermediate duration and is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

"[Rocuronium's] rapid onset of action allows almost all patients to be intubated within approximately one minute of its administration," the company said in a news release, adding that the lack of metabolites further contribute to its safety for continuous infusion.

Rocuronium (marketed as Zemuron/Esmeron) previously was approved by the US Food and Drug Administration, Health Canada, and the European Commission.

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