Sativex Archives - Green Market Report

StaffJune 28, 2022
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4min5260

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced top-line results from the Phase 3 RELEASE MSS1 trial (NCT04657666) evaluating nabiximols oromucosal spray (JZP378, or Sativex , ex-U.S.) on clinical measures of spasticity in individuals with multiple sclerosis (MS). The RELEASE MSS1 trial did not meet the primary endpoint of change in Lower Limb Muscle Tone-6 (LLMT-6) between baseline and Day 21, as measured by the Modified Ashworth Scale (MAS).

“We remain committed to the nabiximols program and are actively assessing the RELEASE MSS1 trial results, which will be presented at a future medical meeting. We look forward to additional data from two other ongoing trials that have the potential to support a U.S. FDA New Drug Application submission,” said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development at Jazz Pharmaceuticals. “I would like to extend a heartfelt thank you to all those who supported and made this study possible, including the patients who were enrolled, their families, our investigators, staff, and all of the dedicated Jazz employees.”

The Sativex or nabiximols oromucosal spray is a complex botanical mixture formulated from extracts of the cannabis sativa plant and contains the cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), as well as other cannabinoid and non-cannabinoid components. Nabiximols oromucosal spray (known as Sativex ex-U.S. and first approved in the U.K. in 2010) has been approved in 29 countries for the treatment of adult patients with moderate to severe spasticity due to MS who have not responded adequately to other anti-spasticity medication based on previously completed clinical trials.

Multiple sclerosis (MS) spasticity is one of the most common motor symptoms associated with MS. MS spasticity often manifests as involuntary muscle stiffness and/or spasms, occurring in up to 84% of individuals with MS, and approximately one-third of individuals with MS still live with uncontrolled spasticity symptoms. However, MS spasticity can also lead to pain, sexual dysfunction, dysarthria, fatigue, depression and anxiety, mobility impairment, bladder and bowel dysfunction, and sleep disturbances. Less than half of individuals with MS receiving treatment for spasticity are satisfied with the current treatment regimens and 41% of physicians are dissatisfied with current treatment regimens.

Despite the disappointment of this study, there are two additional, ongoing Phase 3 trials for the treatment of MS:

  • RELEASE MSS3: A Phase 3 multicenter, double-blind, placebo-controlled trial evaluating the efficacy of nabiximols oromucosal spray, compared to placebo, when added to standard of care, for the improvement of muscle spasms associated with MS over a 12-week treatment period. The estimated enrollment is 446 participants.
  • RELEASE MSS5: A Phase 3 multicenter, randomized, double-blind, placebo-controlled, 2-treatment, 2-period, crossover trial evaluating the effect of multiple doses of nabiximols oromucosal spray compared to placebo on a clinical measure of velocity-dependent muscle tone in the lower limbs (Lower Limb Muscle Tone-6 [LLMT-6]) in participants with MS over a 3-week treatment period. The estimated enrollment is 190 participants.

 


Debra BorchardtJune 30, 2020
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5min29590

GW Pharmaceuticals plc (NASDAQ:GWPH) has pushed the legalization of cannabis ahead with its work on the drug Epidiolex. Now the company is making its plans for its other cannabis drug Sativex known and it’s impressive and hopeful.

The company is announcing its plans for its pipeline product nabiximols to the U.S. market. This strategy includes multiple opportunities for the submission of an initial New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), the earliest of which could occur in 2021.

“We are excited to present the details of our clinical program and regulatory strategy for nabiximols, which we believe support the potential for a substantial near-term commercial opportunity in the U.S. Following constructive meetings with the FDA, we are now commencing a Phase 3 clinical program that provides multiple opportunities for an NDA submission, including as early as 2021”, stated Justin Gover, GW’s Chief Executive Officer. “Beyond the initial target indication of MS spasticity, our Phase 3 clinical program is designed to achieve a broad spasticity label over time. This development strategy, together with the long-term exclusivity potential of nabiximols, provides GW with confidence that this product should represent a significant value driver for GW.”

What Is Nabiximols?

According to GW Pharma, 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 a mouth spray. The commercial name outside the U.S. is Sativex and it is commercially available for the treatment of MS spasticity in numerous countries.

The biotech company outlined the following plans for Sativex:

MS Spasticity Clinical program

  • Three positive Phase 3 MS spasticity trials already completed outside of the U.S.
  • Five new MS Spasticity Phase 3 trials are expected to commence in H2 2020 (2) and H1 2021 (3), any one of which we believe could enable a NDA submission
    • Phase 3 muscle tone studies – placebo-controlled cross-over design
      • N=52; Expected start: Q4 2020
      • N=190; Expected start: Q1 2021
      • N=36 (nabiximols responders); Expected start: Q1 2021
    • Phase 3 spasm frequency studies – placebo-controlled parallel group
      • N=450; Expected start: Q4 2020
      • N=~200 (nabiximols responders); Expected start: Q2 2021

Spinal Cord Injury (SCI) spasticity clinical program

  • Three SCI trials are expected to be initiated in 2020 and 2021
    • N=~100 (observational clinical discovery study); Expected start: Q4 2020
    • N=~100 (muscle tone in nabiximols responders); Placebo-controlled parallel group design. Expected start: Q2 2021
    • N=~400 (spasm frequency); Placebo-controlled parallel group design. Expected start: H2 2021

            This second spasticity indication may lead to broad anti-spasticity labeling and usage.

Post Traumatic Stress Disorder (PTSD) clinical program

  • We are also exploring the potential of nabiximols to reduce sleep disturbance symptoms, as well as anxiety and irritability, in patients with PTSD
  • A Phase 2/3 study in PTSD will have approximately 325 subjects and is anticipated to be initiated in H1 2021

Stock Performance

GW Pharmaceuticals stock has moved higher over the past six months. The stock hit a low of $72 in March and was recently trading at $121. It looks to be moving higher based on the news for Sativex.


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The Green Market Report focuses on the financial news of the rapidly growing cannabis industry. Our target approach filters out the daily noise and does a deep dive into the financial, business and economic side of the cannabis industry. Our team is cultivating the industry’s critical news into one source and providing open source insights and data analysis


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