GW Pharmaceuticals, a biopharmaceutical company, has opened a phase III Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to conduct a pivotal efficacy and safety clinical programme to evaluate Sativex for the treatment of spasticity due to multiple sclerosis (MS). Sativex is currently approved in 22 countries outside the US as a treatment for MS spasticity.

The proposed US phase III programme will be conducted under the agreement with GW’s licensing partner for Sativex, Otsuka Pharmaceutical Co. Ltd. Under the terms of GW’s agreement with Otsuka, Otsuka is responsible for wholly funding the MS phase III clinical programme, as is the case with the current phase III cancer pain programme.

As part of its MS spasticity IND application, GW requested feedback from the FDA on key features of the proposed single phase III trial protocol. GW expects to work with the FDA over the coming months to incorporate FDA feedback and to finalize the protocol design, which may include a request for Special Protocol Assessment (SPA). GW expects the phase III trial to commence in 2014.

Cancer pain remains the initial target indication for Sativex in the US and it is intended that MS spasticity would represent a future second indication for the US market. GW and Otsuka are currently undertaking a phase III clinical trial programme for Sativex in cancer pain and results from two pivotal phase III trials are expected in 2014.

"With results from our US phase III programme in cancer pain due next year, this new phase III IND provides us with the opportunity to broaden the future US market potential for Sativex to include MS spasticity. As such, this new IND represents an important extension of GW’s and Otsuka’s ambitions for Sativex in the US,” stated Justin Gover, chief executive officer of GW. “We now look forward to working with the FDA to gain agreement on the required program to enable a future filing of an NDA for the MS indication."

Sativex is an investigational new product composed primarily of two cannabinoids: CBD (cannabidiol,) and THC (delta 9 tetrahydrocannabinol). Sativex is administered as a metered dose oro-mucosal spray each 100µL spray contains 2.7mg THC and 2.5mg CBD. The Sativex formulation is standardized by both composition and dose and is supplied in small spray vials. The components of Sativex have been shown to bind to cannabinoid receptors that are distributed throughout the central nervous system and in immune cells.

Cancer pain represents the initial target indication for Sativex in the US. A phase III clinical trials programme is currently underway to evaluate Sativex to treat persistent pain in patients with advanced cancer who experience inadequate pain relief from optimized chronic opioid therapy. Results from two pivotal phase III cancer pain trials are expected in 2014.

Outside the US, Sativex is approved in 22 countries as a treatment for Multiple Sclerosis spasticity.

In February 2007, GW and Otsuka entered into an exclusive license agreement to develop and market Sativex in the US. Under the terms of this agreement, the costs of pre-clinical and clinical required for US approval are to be wholly funded by Otsuka.

Multiple sclerosis (MS) is a degenerative neurological condition, which is associated with a wide range of distressing and disabling signs and symptoms. MS is the most common disabling disease of the CNS affecting young adults.

Spasticity is a common symptom associated with MS and is a major contributor to disability. It is caused by damage to the nerves in the central nervous system which carry messages instructing muscles how to move resulting in an involuntary muscle overactivity.

In a survey, 84 per cent of people with MS reported symptoms of spasticity. Moderate, severe or total spasticity is reported in 34 per cent of individuals. Symptoms include loss of mobility, painful spasms, stiffness and / or weakness of muscles. As a consequence an individual may have difficulty in walking, picking up objects, washing, dressing and other everyday activities involving movement.In addition to causing a great deal of distress to the person with MS, mood, self-image and motivation can also be affected.

GW is focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas.