- Results from post-hoc analysis of phase 3 clinical study show nabiximols was well-tolerated and provided continued reductions in spasticity for individuals who remained on therapy
- Analysis of two placebo-controlled randomized trials shows nabiximols had no notable negative effects on cognition, depression, or suicidality
The data are planned for presentation at MSVirtual2020, the 8th joint meeting of the
“We are pleased to share these study results, which highlight additional clinical evidence of the favorable safety profile and efficacy of nabiximols, with the medical community at MSVirtual2020,” said
The first presentation (P1109) includes results from a post-hoc analysis of a Phase 3 clinical trial (GWSP0604) conducted in two phases (A & B) to assess the favorable safety profile and potential clinical efficacy of nabiximols in persons with MS-associated spasticity. Phase A of the analysis (4 weeks) evaluated the safety profile of nabiximols in responders vs nonresponders; all participants received nabiximols in this single-blind phase and 266 were labeled responders to treatment with nabiximols out of 572 enrolled. Results from Phase A showed that fewer responders reported an adverse event (AE) compared to those who did not respond to treatment (40 percent vs. 53 percent). AEs were similar between the groups, except dizziness, which occurred more frequently in nonresponders vs responders (18 percent vs 10 percent). At the end of Phase A, mean percent decrease in spasticity numeric rating scale (NRS) was 44 percent for responders vs 3 percent for nonresponders.
In Phase B, 241 of the 266 responders from Phase A were randomized to nabiximols (n=124) or placebo (n=117) to evaluate the potential clinical efficacy of nabiximols vs placebo (12 weeks). At the end of Phase B, those receiving nabiximols experienced a significantly greater mean percent decrease in spasticity numeric rating scale (NRS) from Phase A baseline compared to placebo (46 percent vs 34 percent; P=0.011) as well as a significantly greater mean percent decrease in spasm frequency (44 percent for nabiximols vs 24 percent for placebo; P=0.006). More caregivers of participants on nabiximols also reported an improvement from Phase A baseline on the Caregiver Global Impression of Change (CGIC) scale (68 percent for nabiximols vs 43 percent for placebo). During Phase B, 53 percent of participants on nabiximols reported one or more new AEs vs 49 percent on placebo.
Overall results showed that nabiximols was well tolerated and provided continued benefit to individuals who remained on therapy.
“This analysis further clarifies the potential clinical efficacy and favorable safety profile of nabiximols for the treatment of MS-associated spasticity, where there has been little therapeutic innovation in decades in the United States,” said Dr.
The second virtual presentation (P1094) will share results of an assessment of the impact of nabiximols on other outcomes, such as cognition, depressive symptoms, and suicidality in persons with MS-associated spasticity. The analysis used data from two placebo-controlled, randomized trials: GWSP0604 (referenced above) (12 weeks) and GWMS1137 (48 weeks). Mood and suicidality were assessed using the Beck Depression Inventory-II (BDI-II). In GWMS1137, suicidality was additionally assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) and working memory/processing speed was assessed using the Paced Auditory Serial Addition Test (PASAT). Results of the analysis showed that nabiximols had no notable negative effects on cognition, depression, or suicidality.
“Concerns related to the mental health impact of unregulated cannabinoid therapies remain and this analysis sought to determine whether nabiximols had any such risks within the MS populations studied,” said Dr.
GW, and its
About Nabiximols
Nabiximols is expected to enter pivotal Phase 3 development in
Nabiximols is a complex botanical medicine formulated from extracts of the cannabis plant that contains the principal cannabinoids THC and CBD and also contains minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols, and triglycerides. The product is administered as an oral spray.
Nabiximols is known as Sativex® outside of
About
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. The Company’s lead product, EPIDIOLEX® (cannabidiol) oral solution is commercialized in the
Forward-looking statement
This news release contains forward-looking statements that reflect GW's current expectations regarding future events, including statements regarding the timing of clinical trials, the timing of regulatory filings and approvals, the timing and outcomes of regulatory or intellectual property decisions, and the clinical benefits and commercial potential of nabiximols (marketed as Sativex® outside the US). Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the risks and uncertainties which can be found in GW’s filings with the
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1 Sativex Oralmucosal Spray, SmPC, https://www.medicines.org.uk/emc/product/602.
2 Markova et al,
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