MILL VALLEY, Calif.--(BUSINESS WIRE)--K-PAX Pharmaceuticals, Inc., a pioneer in immune function and energy metabolism medicines, today announced that the United States Patent and Trademark Office (US PTO) has issued an U.S. Patent for a repurposed version of methylphenidate (No.13/530,673) to the company. The patent is directed to compositions and methods for the treatment of Chronic Fatigue Syndrome (CFS) and other medical conditions associated with fatigue when methylphenidate is combined with a key combination of micronutrients (KPAX002).

K-PAX Pharmaceuticals, a privately-held biotechnology company is developing a repurposed version of methylphenidate (KPAX002), to improve its safety and efficacy for a variety of new indications, including CFS, by combining it with a key combination of mitochondrial support nutrients. Methylphenidate has a long history in medical care, is marketed as brand name Ritalin™ by Novartis International AG for the treatment of Attention Deficit Disorder, and is also currently available in a generic version - methylphenidate hydrochloride.

“Our team at K-PAX Pharmaceuticals is very excited that the US PTO has granted patent protection to a breakthrough therapy with the potential to meet this critical unmet need,” said Dr. Jon Kaiser, the Company’s Chief Executive Officer and Chief Medical Officer. “This newly issued patent provides the Company with broad claims to many possible uses for KPAX002. Our proprietary combination of key nutrients makes it possible to unlock the potential of a methylphenidate molecule that is well known and trusted by the medical community.”

A peer-reviewed paper on this treatment method was recently published in the International Journal of Clinical and Experimental Medicine (IJCEM)1. It details the theory behind how this new and improved version of methylphenidate, tested and refined for many years in clinical practice, demonstrates great potential by meeting defined clinical outcomes associated with the symptoms of CFS. This innovative treatment also has the potential to alleviate fatigue associated with other medical conditions such as fibromyalgia and autoimmune disorders.

In addition to the just published proof-of-concept trial, K-PAX Pharmaceuticals has also recently completed a Phase IIa double-blind, placebo-controlled trial, the findings of which also support KPAX002’s potential as a safe and effective treatment for CFS.

KPAX002 is an investigational mid-Phase II compound with positive Phase I and Phase IIa data demonstrating significant potential as a treatment for CFS. The U.S. Food and Drug Administration (FDA) has waived preclinical testing and the opportunity to obtain market exclusivity under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act is strong.

ABOUT Chronic Fatigue Syndrome (CFS)

The Centers for Disease Control (CDC) defines Chronic Fatigue Syndrome, or CFS, as a debilitating and complex disorder characterized by profound fatigue that is not improved by bed rest and which may be worsened by physical or mental activity. It is classified by the FDA as a “serious unmet medical need”. There are currently no approved treatments for this disease which afflicts an estimated 2.5 million people in the U.S. according to the CDC.

ABOUT K-PAX Pharmaceuticals

K-PAX Pharmaceuticals, based in Mill Valley, California, is a privately-held biotechnology company pioneering medicines to strengthen immune function and support optimal energy metabolism. Learn more at http://www.kpaxpharmaceuticals.com

Kaiser, JD. A prospective, proof-of-concept investigation of KPAX002 in chronic fatigue syndrome. Int J Clin Exp Med 2015;8(7):11064-11074.