Date: 2014-04-07
Type of information: Results
phase: 1
Announcement: results
Company: Flamel Technologies (France)
Product: Micropump® technology applied to sodium oxybate
Action mechanism:
Disease: narcolepsy
Therapeutic area: Neurological diseases
Country:
Trial
details: The trial was designed as a 16 subject four-way crossover evaluating three different formulations of Micropump sodium oxybate and Xyrem® at a nightly dose of 4.5g (two doses of 2.25g for Xyrem) with an extension phase at 6g for successful Micropump formulations. Each subject consumed a standard meal two hours prior to dosing. Subjects were instructed to maintain a consistent meal time and dosing schedule throughout the study. When a subject took Xyrem® they were instructed to take the second dose 4 hours after the first dose. Two subjects dropped out of the study prior to the completion of the 4.5g dosing portion for reasons unrelated to drug. The key data for the 14 evaluable subjects at 4.5g are:
Onset of action similar to Xyrem®
Cmax lower than Xyrem®
Mean blood concentration (ug/ml) at hours 7 and 8 similar to Xyrem®
For the extension phase of the study, two formulations were moved forward for dosing at 6g. Thirteen subjects were evaluable as one subject dropped out for a reason unrelated to drug. The profiles for both formulations were consistent with expectations. The current study will continue to treat subjects at higher doses.
Latest
news: * On April 7, 2014, Flamel Technologies has announced that its First-in-Man (FIM) clinical study in healthy volunteers using its proprietary Micropump® technology applied to sodium oxybate has identified formulations that demonstrate the potential to eliminate the second nighttime dose for patients suffering from narcolepsy. The current dosing regimen for the standard of care, Xyrem® (sodium oxybate), in the United States is two equal, divided doses: the first dose at bedtime and the second dose 2.5 to 4 hours later. The elimination of the second dose for narcolepsy patients would not only provide more convenience,but may improve the benefit sodium oxybate provides as there will be no disruption to nighttime sleep. The potential for additional benefits, including improved safety, will be studied. The key data for the 14 evaluable subjects at 4.5g are:Onset of action similar to Xyrem, Cmax lower than Xyrem, Mean blood concentration (ug/ml) at hours 7 and 8 similar to Xyrem. For the extension phase of the study, two formulations were moved forward for dosing at 6g. Thirteen subjects were evaluable as one subject dropped out for a reason unrelated to drug. The profiles for both formulations were consistent with expectations. The current study will continue to treat subjects at higher doses. Given these results, Flamel plans to begin a new clinical study before the end of 2014 in a larger number of subjects further evaluating its formulations as well as certain pharmacodynamic endpoints. This study is not expected to be a registration study. Flamel plans to meet with regulatory authorities prior to embarking upon registration studies which are expected to begin prior to the end of 2015.
