Profile: Zynerba Pharmaceuticals Inc (ZYNE.OQ)
13 Jan 2017
Zynerba Pharmaceuticals, Inc., incorporated on January 31, 2007, is a specialty pharmaceutical company focused on developing and commercializing synthetic cannabinoid therapeutics formulated for transdermal delivery. The Company is evaluating approximately two product candidates, ZYN002 and ZYN001, in over five indications.
The Company's ZYN002 is a synthetic cannabidiol (CBD) formulated as a permeation-enhanced gel for transdermal delivery. ZYN002 is being developed as a clear that is designed to provide controlled drug delivery with once- or twice-daily dosing. Because CBD is virtually insoluble in water, the Company uses ethanol and propylene glycol as solubilizing agents and Transcutol HP as a permeation enhancer. All excipients in the gel are classified as generally recognized as safe (GRAS) and are used in transdermal products. The permeation enhancer in ZYN002 increases the delivery of CBD through the layers of the skin and into the circulatory system. Transdermal delivery allows the CBD in ZYN002 to avoid stomach acid degradation and the first-pass liver metabolism that occurs with oral or oral mucosal delivery methods. Drugs applied transdermally are absorbed across the skin directly into the systemic circulation.
The Company has initiated a standard toxicology program for ZYN002 with the clinical program. The toxicology program consists of single-dose toxicology, multiple-dose toxicology, reproductive studies and carcinogenicity studies. The Company has initiated a second Phase I clinical trial for ZYN002. The Company intends to study ZYN002 in patients with refractory epilepsy, osteoarthritis and Fragile X syndrome.
The Company's ZYN001 is a pro-drug of tetrahydrocannabinol (THC) that enables transdermal delivery through a patch. The transdermal patch is a non-invasive and non-oral dosage form of method of delivery. The Company intends to test the ZYN001 patch for application to the arm, back and thigh. It intends to study ZYN001 for the treatment of fibromyalgia and peripheral neuropathic pain.
The Company competes with GW Pharmaceuticals, PLC, Insys Therapeutics, Inc., Neuren Pharmaceuticals, Meda AB, Marinus Pharmaceuticals and Nemus Bioscience, Inc.
Zynerba Pharmaceuticals Inc
80 W. Lancaster Avenue, Suite 30
DEVON PA 19333
Company Web Links
- BRIEF-Zynerba Pharmaceuticals posts Q3 loss per share of $0.67
- BRIEF-Zynerba Pharmaceuticals initiates Star 2 open-label extension clinical trial for ZYN002 CBD gel
- BRIEF-Zynerba provides clinical update for lead development candidates - ZYN001 and ZYN002
- BRIEF-Zynerba reports inducement grant to new chief financial officer
- BRIEF-Zynerba enters into an open market sale agreement with Jefferies