Tones-2 study design
Jazz Pharmaceuticals (JAZZ) has been evaluating the potential of its reuptake inhibitor for the dopamine and norepinephrine neurons, JZP-110, in controlling excessive sleepiness and obstructive sleep apnea in narcolepsy patients in three separate phase-3 trials. JAZZ plans to file new drug application for JZP-110 in these indications in late 2017.
In its Tones-2 study, JAZZ studied the efficacy and safety of JZP-110 to control excessive sleepiness in narcolepsy patients over a period of 12 weeks. While 239 patients were enrolled in this trial, certain technical problems reduced the intent-to-treat population to only 231. These patients were distributed in four arms, with one group receiving placebo, while patients in other three groups received 75 mg, 150 mg, and 300 mg dosages of JZP-110, respectively.
The co-primary endpoints in this trial involved one objective test, the MWT (maintenance of wakefulness test), and a subjective test based on changes in the ESS (Epworth Sleepiness Scale).
In the former test, enrolled patients were observed over a period of 12 weeks to study how long they managed to stay awake in an environment conducive to sleep. The latter test measured the likelihood of a patient falling asleep. The secondary endpoint was based on the PGIc (patient global impression of change scale), which is essentially a self-assessment report of the patient commenting on the changes in severity of excessive sleepiness.
JAZZ noted the dose dependency in this trial, with patients on higher doses of JZP-110 managing to stay awake for longer time periods. These results were demonstrated by the end of the first week and continued through all 12 weeks of the study.
Patients on the placebo managed to stay awake for an average of 2.1 minutes at the end of 12 weeks, while those on a 75-mg JZP-110 dose could stay awake for an average time of 4.7 minutes. However, at the higher 150-mg and 300-mg dosages, patients demonstrated higher wakefulness periods of 9.8 minutes and 12.3 minutes, respectively.
JZP-110 also showed a statistically significant improvement on the ESS and PGIc scales, while the safety and tolerability were similar to previous phase-2 trials.
JZP-110 is thus expected to reduce the concentration risk for JAZZ and help it pose stiffer competition to narcolepsy players like Teva Pharmaceuticals (TEVA), Mylan (MYL), and Allergan (AGN). Notably, the Vanguard Health Care ETF (VHT) has ~0.24% of its total portfolio holdings in JAZZ.
Now let’s discuss JZP-110’s research program for obstructive sleep apnea.
JAZZ has estimated that ~6.0 million people in the US suffer from obstructive sleep apnea or excessive sleeping, while ~60,000 are affected by narcolepsy.
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