Allowed patent application covers elements to assure the safe use of fenfluramine
for epilepsy treatment
The Type A meeting was conducted to review the two issues identified in the Refusal to File letter issued by the FDA on April 5, 2019: first, certain non-clinical studies were not submitted to allow assessment of the chronic administration of fenfluramine
; and, second, the application contained an incorrect version of a clinical dataset.
Fen-Phen, which is a combination of fenfluramine
and phentermine, was removed from the market in September of 1997, after reports showed that is caused valvular heart disease and pulmonary hypertension.
Zogenix Inc (NASDAQ: ZGNX) has recorded positive top-line results in the second confirmatory Phase 3 trial of its investigational drug, ZX008 (low-dose fenfluramine
hydrochloride), in children and young adults with Dravet syndrome, the company revealed on Thursday.
trials for patients with a rare, devastating form of epilepsy was also introduced and Cook Children's celebrated its 10th year anniversary of Deep Stimulation Surgery (DBS) for pediatric patients.
Furthermore, removal of some approved antiobesity drugs (fenfluramine
, dexfenfluramine, sibutramine, rimonabant) because of safety issues might be a possible explanation for the reluctance of some physicians to prescribe this class of drugs.
 published a placebo treatment followed by randomized cross-over trial in which 15 children with ASD were treated with fenfluramine
. This type of SSRI treatment increases serotonin release at a higher dose.
In another personal commentary, Kirsch details AHP's failure in the mid-1990s to conduct clinical testing on the cocktail of the already-approved drugs fenfluramine
and phentermine (fen-phen) when used in combination as a weight-loss product.
Amphetamines used in weight management, such as sibutramine, fenfluramine
and dexfenfluramine, have been involved with cardiovascular side effects such as hypertension and pulmonary arterial hypertension (3-5).
A neuroscientist in the audience raised a possible safety concern regarding MDMA: If the drug has an agonist effect on serotonin receptors, couldn't it have cardiac side effects similar to those of fenfluramine
, a drug now banned because it stimulated the abundant 5HT-2b receptors present in the heart, resulting in increased risk of pulmonary hypertension and other adverse cardiovascular effects?
As part of the deal, Zogenix acquires global development and commercialisation rights to the low-dose fenfluramine
Brabafen for the treatment of Dravet syndrome, a form of intractable epilepsy that begins in infancy.