was the first ANDA applicant to submit a substantially complete ANDA with Paragraph IV certification for sodium oxybate
oral solution, 500 mg/mL and therefore is eligible for 180 days of generic drug exclusivity.
Because of safety risks, Xyrem is subject to restrictions on prescribing and dispensing, and sodium oxybate
will be subject to comparably strict controls, which include dispensing only by certified pharmacies that ship directly to patients.
The company said FT218 is a once-nightly formulation of sodium oxybate
utilising its proprietary Micropump technology that is being studied for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy.
Adverse effects of sodium oxybate
include slower breathing, confusion, depression, edema, dizziness, vomiting, bedwetting, and sleepwalking.
The researchers gave zolpidem, sodium oxybate
(Xyrem) and a placebo to 28 men and women between the ages of 18 and 39 who were normal sleepers, allowing several days between doses to allow the pharmaceuticals to leave their bodies.
, marketed as Xyrem, is used to treat narcolepsy.
therapy provides multidimensional improvement in fibromyalgia: results of an international phase 3 trial Ann Rheum pis.
The Food and Drug Administration has decided that the sedative-hypnotic drug sodium oxybate
cannot be approved for treatment of fibromyalgia, based on the information currently included in the approval application, the manufacturer has announced.
The statement issued by Jazz Pharmaceuticals noted that the FDA's "complete response letter" said that the new drug application for sodium oxybate
cannot be approved "in its present form'" and cited the need for more clinical studies.
Although hydrophilic like baclofen, GHB, which is also known as sodium oxybate
and is FDA-approved for cataplexy due to narcolepsy, might have an advantage because of carrier-mediated transfer across the blood-brain barrier.
The concerns that the Jazz statement said were outlined in the letter reflect those expressed by members of two FDA advisory panels at an August meeting held to review the data on sodium oxybate
for the fibromyalgia indication.
55) Sodium oxybate
, the sodium salt of a metabolite of gamma-aminobutyric acid, was found to help FMS symptoms during its open-label trial for patients with narcolepsy.
Jazz Pharma purchases its worldwide supply of sodium oxybate
, the API in Xyrem (sodium oxybate
) oral solution, from Lonza.