GW Pharmaceuticals is planning to continue recruiting patients into two pivotal Phase 3 clinical trials of Sativex (nabiximols), an oral spray that contains cannabis extracts and is being investigated as a potential add-on therapy for people with multiple sclerosis (MS) and spasticity.
The company also is planning to launch three additional clinical trials in the U.S. focused on exploring Sativex’s therapeutic potential for the treatment of spasticity (muscle stiffness or spasms) associated with MS.
GW Pharmaceuticals anticipates it will announce preliminary data from at least one of these studies in the coming months. If positive, these findings may support the submission of an application requesting the therapy’s approval for this indication in the U.S.
“Our goals in 2021 include … advancing multiple US pivotal trials for nabiximols in the treatment of MS spasticity, with the first data readout expected this year,” Justin Gover, CEO, said in a press release.
Sativex is an oral spray that contains cannabidiol (CBD) and tetrahydrocannabinol (THC), two of the most abundant cannabinoids found in the cannabis plant. The medication is approved in Europe and other regions as an add-on therapy to alleviate spasticity in MS patients with moderate-to-severe muscle tightness, who failed to respond to treatment with other anti-spastic agents.
In the U.S., two pivotal Phase 3 trials (NCT04203498 and NCT04657666) are ongoing to assess the safety and effectiveness of Sativex, compared with a matched placebo, at easing spasticity symptoms in adults with MS.
The first trial intends to enroll approximately 446 patients. They will be assigned randomly to receive either Sativex or a placebo, both self-administered as on oral spray in the morning and evening, up to 12 times daily for 12 weeks.
The study’s main goal is to assess whether Sativex outperforms a placebo at lowering the frequency of muscle spasms in MS patients. Additional study goals include the therapy’s safety and effects on several vital signs and clinical parameters.
The trial is currently recruiting participants at two sites in Poland. Information on U.S. trial sites is yet to be announced. Top-line data from this trial is expected in 2022.
The second pivotal trial aims to enroll 52 MS patients who failed to experience adequate symptom relief after receiving other anti-spasticity medications.
Like the previous study, patients participating in this trial will be treated with Sativex, or a placebo, both self-administered as an oral spray in the morning and evening, up to 12 times daily for 12 weeks.
Yet, unlike the previous study, the main goal of this trial is to assess the effects of treatment on lower limb muscle tone. This study is scheduled to conclude by May.
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