Pisgah Labs, a drug product development company and an active pharmaceutical ingredient manufacturer (API) located in western North Carolina, has received a patent allowance in a series of patent applications. The US Patent & Trademark Office (USPTO) has notified Pisgah Labs, Inc. (http://www.pisgahlabs.com) that a patent application related to a therapeutically significant family of pharmaceutical polymorphic compositions of imipramine pamoate has been allowed. The patent application also includes methods of manufacturing, purifying and use in pharmaceutical preparations.
Interestingly, imipramine is reported to exhibit therapeutic benefit besides the treatment of depression. Imipramine has been used in the treatment of fibromyalgia, childhood nocturnal enuresis and other types of urinary incontinence, trichotillomania, post-traumatic stress disorder, panic disorder and to provide analgesic-like relief for neuropathic pain. Researchers have reported a relationship between imipramine binding, serotonin uptake and the link between fibromyalgia and depression. Medical treatments for fibromyalgia are well-documented on the University of Maryland Medical Center's website:
In regard to imipramine pamoate, used in the well-known product Tofranil PM(R), some may say activity level required was disproportionate to the achievement. "Not so," says Pisgah's president, Bill Bristol. "From what we learned while focused on this imipramine we have leveraged this knowledge into a new business opportunity for the Company. Our discoveries led to additional patent filings related to abuse-deterrent prescription drugs like oxycodone and hydrocodone. We realized we could apply our findings to pain products to achieve selective dissolution profiles. From our early work with imipramine, we're now heavily engaged in developing abuse-deterrent forms of narcotics including hydrocodone - the most abused drug in America."
Pisgah Labs' intellectual property development has led to more than ten filed applications related to market and regulatory desirable performance features like ineffectiveness when snorted or injected; and grinding or chewing has no effect on accelerating active ingredient release. Extraction of the active, or to practice a dangerous abuse route called "dose dumping," is dramatically hindered. Observations so far indicate the chemistry is applicable to all of the potentially abused drugs. Pisgah is actively developing a product stable of anti-abuse opioid products and breathing life into medically necessary, but often abused, pain medications.
Pisgah anticipates additional patent allowances soon supporting its commercial (imipramine) efforts and the broader foray into abuse-deterrent products.