Jazz Pharmaceuticals PLC (NASDAQ:JAZZ) recently revealed that it published the results of its phase 3 clinical data evaluating Xywav, an oral solution that the company has been developing as a cataplexy treatment.
The company recently published the findings from the study in a journal called SLEEP which is befitting considering that Jazz has been developing Xywav as a potential therapy for narcolepsy. The latter is a condition where patients experience too much sleepiness during the day. Jazz revealed in the published work that Xywav hit its primary and secondary endpoints.
“This publication reinforces the option Xywav provides for those living with cataplexy or EDS associated with narcolepsy,” said Robert Iannone, the head of the research and development division at Jazz Pharmaceuticals.
Dr. Iaonone also noted that the FDA approved Xywav as a cataplexy and EDS treatment for individuals that suffer from narcolepsy. The pipeline drug earned its approval from the FDA courtesy of the findings from the Phase 3 study. 201 participants enrolled in the study and 134 of them were randomized. The participants include those that were involved in the sodium oxybate where some were treated with other anticataplectic treatments while others were not.
Researchers observed a surge in the number of median weekly cataplexy attacks especially in the randomized patients that received the placebo compared to their counterparts treated with Xywav. The median ESS scores at the end of the study had increased for patients treated with Xywav. There were some adverse reactions from some patients but they were not severe. They include diarrhea, nausea, loss of appetite, anxiety, hyperhidrosis, parasomnia, dizziness, and vomiting. They were thus tolerable adverse effects that did not put the test subjects at any risk.
Jazz Pharmaceuticals executives also revealed that they plan to pursue the launch of the treatment before the end of 2020. However, Xywav will have to go through Risk Evaluation and Mitigation Strategy (REMS) before the market rollout. The company expressed its commitment to developing effective therapies that will be accessible to patients. It also plans to use proceeds from the sale of those treatments so that it can boost its development pipeline to positively impact even more lives.