
Dr Robert Iannone Discusses Phase 3 Results for Treatment of Idiopathic Hypersomnia
Results from a phase 3 study of Xywav in adult patients with idiopathic hypersomnia exhibited its potential to address this unmet medical need.
Results from Jazz Pharmaceuticals’ phase 3 study of Xywav in adult patients with idiopathic hypersomnia exhibited its potential to address this unmet medical need. Future research is additionally being considered in related areas of neuroscience, such as essential tremor, said Robert Iannone, MD, MSCE, executive vice president of research and development for Jazz Pharmaceuticals.
Transcript
AJMC®: Hello, I'm Matthew Gavidia. Today on the MJH Life Sciences’ Medical World News, The American Journal of Managed Care® is pleased to welcome Robert Iannone, executive vice president of research and development at Jazz Pharmaceuticals.
Jazz Pharmaceuticals
Iannone: Yeah, really exciting news for us recently to hear the positive results from the idiopathic hypersomnia trial. Just to remind you, this was a clinical trial–a Phase 3 trial, double-blind, placebo-controlled, and in what we call a randomized withdrawal design.
So, what we did was we took patients who had idiopathic hypersomnia, and we allowed all of those patients to go on to Xywav during about a 4-month period where they were permitted to titrate their dose up until they had a maximal effect. At the end of the what we call titration period and stable dosing period, patients were assessed for their daytime sleepiness using a scale called the
The next part of the design was to randomly withdraw half of the patients. As I said, it's blinded and placebo-controlled so in a blinded fashion, half of the patients were then converted over to placebo. Then, we again measured that excessive sleepiness during the day using the ESS.
We also measured a patient-reported outcome called the
Then at the end of that 2-week, randomized withdrawal period, patients were then allowed to return again to their Xywav treatment, and we saw again improvement in those symptoms. So, it was a really nice demonstration of improvement from severity, return closer to baseline for those getting placebo, and then again a return up to benefit from the treatment. And I would say overall, the results were really promising in terms of the magnitude of effect that we observed.
AJMC®: To build upon that, with positive results from the phase 3 trial and Fast Track Designation granted by the FDA on Xywav, what are the next steps for this indication? And what other sleep medications are in the pipeline for Jazz Pharmaceuticals?
Iannone: So, Matthew, as you mentioned, Xywav was granted Fast Track Designation for the indication of idiopathic hypersomnia. And that comes when there's a condition such as idiopathic hypersomnia that is severe in nature, and when a new therapy has the potential to address this unmet medical need. So, we were really pleased and feel it's appropriate that Xywav received this designation.
As you know, there are currently no approved therapies in the United States for idiopathic hypersomnia. And so these results with Xywav are really, really encouraging. So, with that, we're working closely with the FDA to find really the appropriate and fastest path to bring this new therapy to patients who desperately need it.
To the second part of your question, Jazz continues to be committed to research and development in the space of sleep medicine. While we don't have any other ongoing phase 3 trials with Xywav, in particular, we're continuing to consider additional research in the area of sleep and narcolepsy, as well as expanding into other related areas of neuroscience, such as essential tremor.
AJMC®: Lastly, do you have any other concluding thoughts?
Iannone: Just that Jazz is really proud to be
AJMC®: To learn more, visit our website at AJMC.com. I’m Matthew Gavidia, thanks for joining us!
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