BLUE BELL, Pa., Jan. 30 /PRNewswire/ -- TheraQuest Biosciences, a development stage pain management company, today announced that the FDA Office of Orphan Products Development has granted Orphan Drug Designation for its high-concentration Capsaicin for the management of postherpetic neuralgia. TheraQuest is seeking a pharmaceutical partner to rapidly progress the development of this opportunity.
Postherpetic neuralgia (PHN) is a chronic, debilitating neuropathic pain syndrome that occurs as a complication of shingles or herpes zoster infection. The pain of PHN is unrelenting and is often described as burning, stabbing or aching. According to Dr. Richard Payne, Professor of Medicine and Director, End of Life Care Institute at Duke University, “In addition to persistent pain, patients with PHN experience episodic pain due to abnormal sensations from normal daily activities such as putting on a shirt or contact with a cool gentle breeze. If untreated, postherpetic neuralgia can adversely affect a patient’s quality of life. Patients frequently fail to obtain complete pain relief with existing treatments or develop troublesome side effects.”
TheraQuest’s high-concentration Capsaicin (TQ-1018) is intended to provide long-lasting pain relief to patients with postherpetic neuralgia. Currently, only low-concentration topical Capsaicin products are available. Topical Capsaicin products are not approved for the treatment of any painful neuropathy.
Najib Babul, PharmD, Chief Executive Officer of TheraQuest, stated, “These low-concentration OTC products provide only modest and inconsistent efficacy in neuropathic pain, and they need to be applied 3 to 4 times a day. We anticipate that a single application of TheraQuest high-concentration Capsaicin, in conjunction with a topical local anesthetic, will provide pain relief lasting weeks to months.”
Babul adds, “We are particularly pleased to have been granted an Orphan Drug Designation for topical capsaicin. Orphan status affords us seven years of market exclusivity, 50% R&D Tax Credits, exemption from FDA Prescription Drug User Fee and access to research grants from the Office of Orphan Products Development for TQ-1018, our high-concentration Capsaicin for the management of postherpetic neuralgia.”
About TheraQuest
TheraQuest Biosciences is a private, development-stage pain management company building a diversified portfolio of pharmaceutical products to address a critical area of unmet medical need. Despite their limitations, current treatments for acute and chronic pain yield worldwide sales in excess of $25 billion. The TheraQuest team has contributed to the development of numerous analgesics approved in the U.S. over the past 20 years. TheraQuest’s strategy is to use its expertise to identify, develop and commercialize product candidates with strong market potential that have lower development costs and reduced regulatory risk than new chemical entities. TheraQuest is headquartered in Blue Bell, Pennsylvania.
TheraQuest is funded in part by BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania and Ben Franklin Technology Partners of Southeastern Pennsylvania. Additional information is available at http://www.theraquestinc.com.
TheraQuest Biosciences, LLC
CONTACT: Najib Babul, PharmD, CEO, TheraQuest Biosciences, LLC,+1-610-272-2071, inquiry@theraquestinc.com
Web site: http://www.theraquestinc.com/
