FSD Pharma reveals temporary FDA approval to submit IND for FSD-201
Category: #health  By Saipriya Iyer  Date: 2020-06-05
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FSD Pharma reveals temporary FDA approval to submit IND for FSD-201

FSD Pharma Inc. has recently announced the temporary approval from the U.S. FDA to submit an IND (Investigational New Drug) application for FSD-201 (ultramicronized PEA or palmitoylethanolamide). This will be used for the treatment of COVID-19 disease that is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Severe cases of COVID-19 are characterized by overexuberant inflammatory responses that may lead to cytokine storm among patients and ultimately face death. The company’s FSD-201 drug consists of anti-inflammatory properties to avert this inflammatory response associated with acute lung injury among hospitalized patients infected with COVID-19.

The company is anticipating the trial of the FSD-201 to be a U.S. multicenter, double-blind, controlled, randomized study to examine its safety and efficacy. The participants will be dosed with 600mg/1200mg of FSD-201 twice a day. Additionally, SOC (standard of care) will be offered in symptomatic patients. Patients with symptoms of influenza or coronavirus such as difficulty breathing, malaise, dry cough, and fever are eligible to participate in the trial.

The primary endpoint of the trial is to examine whether FSD-201 plus SOC offers a significant clinical status improvement. Determining whether it demonstrates additional benefits, assessing the duration to the normalization of body temperature, oxygen saturation improvement, and clinical progression are among the study’s key secondary objectives. This clinical progression includes the duration of hospitalization or mechanical ventilation and length of hospital stay.

The trial or treatment period is likely to last for 14 days. Patients experiencing clinical benefits must continue receiving the assigned treatment until the completion of the study. Palmitoylethanolamide (PEA) acts through various mechanisms, either to activate PPAR-α & GPR55 or indirectly via the inhibition of FAAH. This increases the endogenous levels of AEA (anandamide) and 2-AG (2-arachidonoyl-glycerol), which directly activate CB1 or CB2 receptors as well as TRPV1 channels.

PEA, a fatty acid amide, can potentially down-modulate extra immune response activity that can lead to the physiologic derangement caused by the virus and help curb the pathogenesis of cytokine storm.

Source credit:

https://www.businesswire.com/news/home/20200602005990/en/FSD-Pharma-Receives-U.S.-FDA-Approval-Design



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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