EffRx Pharmaceuticals receives FDA orphan drug designation for EX404

EffRx Pharmaceuticals has received US Food and Drug Administration (FDA) orphan-drug designation for its proprietary metformin-based product, EX404, for treatment of paediatric polycystic ovary syndrome (PCOS).

Also known as Stein-Leventhal syndrome, PCOS is a heterogeneous disorder of chronic anovulation and hyperandrogenism.

The syndrome is believed to occur due to hormonal imbalance caused by increased levels of androgens and insulin in the body.

EffRx Pharmaceuticals chairman and CEO Christer Rosén said the FDA’s orphan drug designation of EX404 is a significant step forward in the clinical development programme.

http://www.pharmaceutical-technology.com/news/newseffrx-pharmaceuticals-receives-fda-orphan-drug-designation-for-ex404-4290237?WT.mc_id=DN_News