NeuroHealing Receives Notice of Allowance from the U.S. Patent and Trademark Office for a New Treatment for Premature Ejaculation

October 13, 2010 (PRLEAP.COM) Business News
Newton, Massachusetts October 13, 2010 NeuroHealing Pharmaceuticals, a private, clinical stage company developing innovative drug treatments for specialty indications based on repositioning neurologically active compounds, announced today that the United States Patent and Trademark Office (USPTO) has awarded a Notice of Allowance for a patent entitled "Modafinil-based Treatment for Premature Ejaculation."

The patent (US Application 12/310,175) will cover broad methods of using modafinil and modafinil isomers to delay ejaculation in males during sexual activity. The allowed claims include use of the short half-life modafinil d-isomer to provide a short duration of the desired pharmacological activity. The patent will also cover the use of modafinil for treating premature ejaculation (PE) using various drug delivery means, including fast-disintegrating tablets and orally dissolving thin films. The combination of these rapid delivery technologies with a short-lived drug is designed for rapid onset and fast clearance, as well as user convenience. The use of the modafinil d-isomer represents a novel mechanistic approach to the treatment of PE.

"Premature ejaculation is the most common male sexual dysfunction and there are no approved drug treatments in the United States. NH02D is an ideal treatment for on-demand use by patients with this disorder." commented Dr. Culley, Professor and Chief of Urology at the University of North Carolina (Chapel Hill) School of Medicine, a NeuroHealing Medical Advisory Board member.

"I look forward to the development of a safe and effective drug with a good profile like NH02D (fast onset, short half-life, non-drowsy, no adverse effect on libido)" said Dr. Michael O'Leary, Professor of Surgery, Harvard Medical School and Senior Urologic Surgeon at Brigham & Women's Hospital, Boston. Dr. O'Leary is also a NeuroHealing Medical Advisory Board member.

About NH02D Program for the Treatment of Premature Ejaculation
NeuroHealing is developing NH02D, the short-acting modafinil d-isomer for the 'on demand' treatment of premature ejaculation. During testing of NH02D in healthy volunteers, the drug was reported to delay ejaculation during sexual activity. Subsequently, the effectiveness of NH02D has been demonstrated in a validated animal model of premature ejaculation in collaboration with Dr. Lesley Marson at the University of North Carolina.

Premature ejaculation is the most prevalent male sexual disorder affecting up to 30 percent of sexually active men and is even more prevalent than erectile dysfunction (with a market of over $4 billion in 2009). Currently, there are no clinically proven products available for the treatment of PE in the United States.

A Medical Advisory Board consisting of an outstanding group of clinicians and researchers who collectively bring substantial experience in the men's sexual health field, in the treatment of premature ejaculation and in PE clinical trials has been assembled to assist the company in the clinical development of NH02D.

About NeuroHealing Pharmaceuticals
NeuroHealing Pharmaceuticals, Inc. is a clinical stage private company developing innovative treatments for specialty indications based on repositioning neurologically active compounds. Clinical stage programs include: NH001 (phase II), a dopaminergic agent to help post traumatic brain injury patients to emerge from a coma, vegetative or minimally consciousness state; NH004 (phase II), an anticholinergic agent in a convenient intra-orally muco-adhesive dissolving film to help treat motor neuron disease patients who suffer from sialorrhea (drooling); and NH02D, a neurologically active compound to treat premature ejaculation.

NeuroHealing Pharmaceuticals, Inc.
David Gwynne, PhD, VP Business Development

Keywords: male sexual dysfunction, clinical trial, drug treatment, modafinil, NH02D