(34) At this time,
sodium oxybate ([gamma]-hydroxybutyric acid [GHB]) is the only drug approved by the US Food and Drug Administration (FDA) for the treatment of both cataplexy and EDS in patients who have narcolepsy with cataplexy.
In conjunction, the Phase III trial, titled "A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of
Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy," recently commenced patient enrollment in Canada, with sites in Europe and the US to be initiated near-term, concluded the company.
Sodium oxybate was increased weekly in 1.5-g increments up to the final dose, with the total treatment lasting 28 days.
If approval is granted,
sodium oxybate's expanded indication would make it the first drug approved for treatment of all the primary symptoms of narcolepsy: excessive daytime sleepiness; fragmented sleep; and cataplexy, the sudden, brief loss of muscle tone frequently experienced by narcoleptics during periods of emotional intensity such as surprise, laughter, or anger.
For example, in addition to good sleep hygiene, an amphetamine such as dextroamphetamine or methylphenidate may be prescribed to help sustain daytime wakefulness, along with
sodium oxybate, a selective serotonin reuptake inhibitor (SSRI) or tricyclic antidepressant to treat cataplexy and other symptoms of REM sleep dysregulation (hypnagogic hallucinations).
In one study, patients on 6 g or 9 g per day of
sodium oxybate had 10 and 16 fewer attacks per week, respectively, compared with 4 fewer attacks per week with placebo.
Sodium oxybate is the low-profile name that has been coined by the manufacturer for GHB, an increasingly popular "club drug" that has been linked to the deaths of 71 recreational drug users and the addiction of many more, according to expert testimony delivered at the hearing.
Flamel Technologies (NASDAQ:FLML) said on Thursday that it has filed a Special Protocol Assessment (SPA) with the US Food and Drug Administration (FDA) for the launch of its pivotal Phase III study of its once nightly Micropump based
sodium oxybate product for the treatment of narcolepsy.
M2 EQUITYBITES-April 1, 2016-Flamel Technologies files SPA with US FDA for once nightly micropump based
sodium oxybateIreland-based Jazz Pharmaceuticals has started patient enrolment in a Phase III clinical trial aimed to evaluate the safety, efficacy and pharmacokinetics of Xyrem (
sodium oxybate) in children and adolescents aged seven to 17 who have narcolepsy with cataplexy, it was announced on Thursday.
And the possible value of
Sodium oxybate (aka: GHB or Xyrem[R]) in alleviating cataplexy associated with narcolepsy.
The committee voted by an 8-1 margin that
sodium oxybate should be prescribed only for those patients who have received a diagnosis of cataplexy.