- Jazz Pharmaceuticals said Tuesday that one of its drugs failed in a late-stage clinical trial focused on treating the muscle spasticity caused by multiple sclerosis.
- The trial enrolled 68 adults whose spasticity wasn’t kept in check by their current medications. Participants were given either a placebo or Jazz’s drug — an oral spray — for three weeks, after which they would switch to the alternate treatment. Jazz reported the study didn’t meet its main goal, as patients given its drug didn’t experience significant enough changes in lower limb muscle tone.
- Data from the trial will be submitted for presentation at a future medical meeting, the company said. Two other, large studies testing Jazz’s drug for spasticity are ongoing. The drug has already been available in parts of Europe for more than a decade, sold under the brand name Sativex.
Sativex was one of two marketed products Jazz picked up through last year’s $7 billion acquisition of GW Pharmaceuticals, a U.K.-based company that used chemicals from cannabis plants to develop medicines. The other product, called Epidiolex, in 2018 became the first cannabis-derived therapy approved by the Food and Drug Administration.
In the seven month period between the GW deal’s closing and the end of 2021, Jazz recorded $464 million in global sales from Epidiolex. Sales of Sativex, meanwhile, totaled just under $13 million.
Jazz hopes to propel Sativex sales by securing an FDA approval. Annabel Samimy, an analyst at the investment firm Stifel, notes how the company’s trio of late-stage clinical trials hinge on “more concrete metrics of muscle tone” and muscle spasms, rather than the patient-reported outcomes that got Sativex rubber-stamped outside the U.S.
In a Tuesday note to clients, Samimy wrote that, while expectations for this first trial were modest, the trial’s failure is still “disappointing,” as a positive readout “could have potentially led to an earlier [approval application] filing on the smaller dataset.”
Jazz, though, has at least two more opportunities to gather supporting evidence for Sativex. Its two larger trials, with estimated enrollments of roughly 450 and 200 patients, were initially anticipated to produce data later this year and early next year, according to a federal clinical trials database. But those readouts have been delayed due to enrollment and site activation issues related to COVID-19. Jazz hasn't specified when to expect results.
While those readouts “should provide a more robust assessment” of Sativex’s effects on muscle tone and spasm frequency, Samimy said the drug remains a small product compared to other Jazz drugs like Epidiolex, the sleepiness medication Xywav and the cancer therapy Rylaze.
Editor's note: This story has been corrected with the latest information regarding the timeline of Jazz's two larger trials.