Wired News – Zynerba Pharma Held Positive Discussion Meeting with FDA for its ZYN002 Development Strategy

Stock Monitor: Horizon Pharma Post Earnings Reporting

LONDON, UK / ACCESSWIRE / March 07, 2018 / Active-Investors.com has just released a free research report on Zynerba Pharma, Inc. (NASDAQ: ZYNE). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=ZYNE as the Company’s latest news hit the wire. On March 05, 2018, the Company, which is a clinical-stage specialty neuropsychiatric pharmaceutical Company, that develops and commercializes innovative pharmaceutically-produced transdermal cannabinoid treatments for rare and near-rare neurological and psychiatric disorders, declared that it has held a positive meeting with the US Food and Drug Administration (FDA) for its planned development strategy for ZYN002 in Fragile X syndrome (FXS). Register today and get access to over 1000 Free Research Reports by joining our site below:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Zynerba Pharma most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

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About Fragile X Syndrome

FXS is a rare genetic developmental disability, which is the main cause of inherited intellectual disability and autism spectrum disorder. At present, this condition affects 1 in 3,600 to 4,000 males and 1 in 4,000 to 6,000 females globally. It is the major cause of intellectual disability in females, and the most common inherited intellectual disability in males. The mutation in the Fragile X Mental Retardation gene located on the X chromosome leads to dysregulation of the endocannabinoid pathway, including the reduction in endogenous cannabinoids (2-AG and anandamide). This disorder can get debilitating as it negatively impacts the synaptic function, plasticity, and neuronal connections. It leads to a range of intellectual disabilities, social anxiety, and memory problems. However, at present, there are no approved therapies for the treatment of FXS.

About ZYN002

ZYN002 is pharmaceutically-produced cannabidiol (CBD) gel that has been designed to provide controlled drug delivery transdermally with once- or twice-daily dosing. It is the first and only CBD that has been formulated as a patent-protected permeation-enhanced transdermal gel.

Currently, it is being evaluated in children and adolescents with FXS, and developmental and epileptic encephalopathies; and in adult epilepsy patients with focal seizures. In fact, Zynerba has already got the US Orphan Drug Designation for the use of CBD as a treatment of FXS.

Zynerba to Initiate Single Pivotal Study for ZYN002

In-line with Zynerba’s discussion with the FDA, the Company plans to initiate a single pivotal study mid-year 2018 to support a New Drug Application (NDA) for ZYN002 in FXS. This study would be a pivotal 14-week randomized, double blind, placebo-controlled clinical trial, in nearly 200 pediatric and adolescent patients in the US, Australia, and New Zealand. In this trial, patients will be randomized 1:1 to receive either one of two weight-based doses of ZYN002, or one of two matching administrations of placebo. It must be noted that all patients will be eligible to enroll in a 12-month open label extension after completing dosing in the pivotal study.

With regards to this new study, the FDA and Zynerba are in agreement that the primary and key secondary endpoints should evaluate evident behaviors in patients with FXS, as reported by the caregiver using the validated Aberrant Behavior Checklist in Fragile X syndrome (ABC-FXS). Once the pivotal trial meets its endpoints, Zynerba may apply for the approval of an indication for the treatment of behavioral symptoms associated with FXS.

Path Forward for ZYN002

ZYN002 has the potential to address core behavioral symptoms of FXS and improve the quality of life for patients and their families.

Armando Anido, Chairman and Chief Executive Officer (CEO) of Zynerba, shared that the FDA meeting was a key milsetone for the Company as it now has a clear path forward for the development of ZYN002 for FXS patients. The Company is pleased with the outcome of the discussion as well as the guidance on trial design.

Dr. Liza Squires, Zynerba’s Chief Medical Officer, shared that currently there are no drugs for treating FXS symptoms. She believes that the Company has designed an efficient pivotal program that includes endpoints that measure clinically-relevant and observable behaviors in patients with FXS. If this trial is successful, it would be the first targeted treatment for FXS symptoms to the large FXS community.

Stock Performance Snapshot

March 06, 2018 – At Tuesday’s closing bell, Zynerba Pharma’s stock dropped 4.55%, ending the trading session at $9.22.

Volume traded for the day: 631.72 thousand shares, which was above the 3-month average volume of 313.48 thousand shares.

Stock performance in the previous six-month period – up 45.20%;

After yesterday’s close, Zynerba Pharma’s market cap was at $119.49 million.

The stock is part of the Healthcare sector, categorized under the Drugs – Generic industry.

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