Become A Featured Company

Pharmather Files for FDA Orphan Drug Designation for Ketamine in Neuropathic Pain

Ryan Allway

November 2nd, 2020

Psychedelics

Pharmather Inc., a wholly-owned subsidiary of Newscope Capital Corporation (“Pharmather” or the “Company”) (CSE: PHRM) and a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, is pleased to announce it has filed an application with the U.S. Food and Drug Administration (“FDA”) to receive Orphan Drug Designation (“ODD”) for ketamine in the treatment of Postherpetic neuralgia (“PHN”), a chronic neuropathic pain syndrome resulting from an outbreak of the herpes zoster virus, also known as shingles. According to Persistence Market Research, the global PHN market is expected to be valued at USD $908.4 million by 2026.

“Our FDA orphan drug application for ketamine to treat PHN is complementary to our growing psychedelic drug development pipeline for rare disorders,” stated Fabio Chianelli, CEO of Pharmather. “We are focused on building a unique ketamine franchise targeting unmet medical needs such as Parkinson’s disease, depression and pain. We are leveraging scientific and clinical data to advance the development of ketamine through the FDA approval process, as well as carving our niche in the rapidly evolving psychedelic pharmaceuticals market.”

The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). The FDA grants ODD status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. ODD would qualify ketamine for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees.

Proposed Use of Ketamine in PHN

Ketamine is an N-methyl-D-aspartate (“NMDA”) receptor antagonist that has the potential to be a treatment option for PHN or as a secondary treatment option for refractory PHN. There is no single treatment option for PHN that surpasses other therapies. Each patient’s case is somewhat different and typically requires a multi-therapeutic approach whereby therapeutic decisions generally are made based on the patient’s symptoms, age, circumstances, and other medical histories. The available treatments are typically inadequate and suboptimal for the relief of pain because of their local action, long titration periods, inadequate dosing and intolerable side effects that are prevalent in topical and systemic treatments. These outcomes lead to poor patient compliance, switching to other classes of medication and low physician and patient satisfaction. In addition, PHN often becomes refractory to treatment. These all lead ultimately to poor quality of life for those suffering with PHN.

In a PHN study, the use of ketamine supported the hypothesis that NMDA receptors are involved in the control of PHN including allodynia and wind-up-like pain, and NMDA receptors also may play a role in the modulation of thermal perception. [1] Ketamine has the potential to become a primary effective treatment, which would simplify the therapeutic approach for PHN and may address the unmet need for more adequate and optimal treatment.

About Postherpetic Neuralgia

PHN is a complication of shingles. Shingles is caused by the reactivation of herpes zoster virus, which has remained dormant for decades in nerve ganglia after resolution of its primary infection (i.e. Chickenpox). [2, 3, 4] It is estimated that there are 1 million cases of herpes zoster annually in the U.S and about 15% to 20% of these cases develop PHN. [7,8]

PHN is defined as the persistent burning, sharp and jabbing pain or the deep and aching pain beginning ninety days after the onset of shingles rash and pain in the same location as the original rash. PHN may be intermittent or consistent and last days, weeks, months and even years. [2, 3, 4]

There is no single treatment that relieves PHN. It often takes a combination of treatments to reduce the pain and is typically based on the patient’s symptoms, age, circumstances, and other medical history. There are four classes of medications that are used to treat PHN: (a) topical local anesthetics, (b) tricyclic antidepressants with noradrenergic activity, (c) medications originally marketed as antiepileptic drugs, and (d) opioids (i.e. morphine, oxycodone and tramadol). [5, 6]

These treatments are often inadequate due to the localized activity of the topical options, and suboptimal dosing and long dose titration periods during which patients remain in unresolved pain in the systemic options. Thus, treatments often lead to non-compliance and/or switching to other medications, which are inadequate. Often the treatments become refractory. For these reasons, PHN results in a poor quality of life for these patients. [7]   Secondary problems associated with PHN include inactivity, depression, and disuse of painful limbs. Non-pharmacological treatments for these secondary problems may include psychological counseling, physical therapy, exercise and acupuncture. [5, 6]

About Pharmather Inc.

Pharmather Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals. Pharmather repurposes psychedelic pharmaceuticals, such as ketamine and psilocybin, for FDA approval to treat disorders of the brain and nervous system. Our team includes world-class strategic partners, advisors and a strong leadership team with a proven track record of success in drug development, business development and capital markets. Our goal is to advance the development of panaceAI™, our drug repurposing artificial intelligence platform, and our clinical product pipeline with ketamine and psilocybin in the treatment of Parkinson’s Disease, depression, pain, traumatic brain injury and stroke. Learn more at: pharmather.com and follow us on Facebook, Twitter and LinkedIn.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

Network Partners

Follow Us on Social Media

LinkedIn

About CFN Media Group

CFN Enterprises Inc. (OTCQB: CNFN) owns and operates CFN Media Group, the premier agency and financial media network reaching executives, entrepreneurs and consumers worldwide. Through its proprietary content creation, video library, and distribution via www.CannabisFN.com, CFN has built an extensive database of cannabis interest, assisting many of the world’s largest cannabis firms and CBD brands to build awareness and thrive. For more information, please visit www.cfnenterprisesinc.com.

Disclaimer: Matters discussed on this website contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time-to-time have a position in the securities mentioned herein and will increase or decrease such positions without notice. The Information contains forward-looking statements, i.e. statements or discussions that constitute predictions, expectations, beliefs, plans, estimates, or projections as indicated by such words as "expects", "will", "anticipates", and "estimates"; therefore, you should proceed with extreme caution in relying upon such statements and conduct a full investigation of the Information and the Profiled Issuer as well as any such forward-looking statements. Any forward looking statements we make in the Information are limited to the time period in which they are made, and we do not undertake to update forward looking statements that may change at any time; The Information is presented only as a brief "snapshot" of the Profiled Issuer and should only be used, at most, and if at all, as a starting point for you to conduct a thorough investigation of the Profiled Issuer and its securities and to consult your financial, legal or other adviser(s) and avail yourself of the filings and information that may be accessed at www.sec.gov, www.pinksheets.com, www.otcmarkets.com or other electronic sources, including: (a) reviewing SEC periodic reports (Forms 10-Q and 10-K), reports of material events (Form 8-K), insider reports (Forms 3, 4, 5 and Schedule 13D); (b) reviewing Information and Disclosure Statements and unaudited financial reports filed with the Pink Sheets or www.otcmarkets.com; (c) obtaining and reviewing publicly available information contained in commonlyknown search engines such as Google; and (d) consulting investment guides at www.sec.gov and www.finra.com. You should always be cognizant that the Profiled Issuers may not be current in their reporting obligations with the SEC and OTCMarkets and/or have negative signs at www.otcmarkets.com (See section below titled "Risks Related to the Profiled Issuers, which provides additional information pertaining thereto). For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity-based compensation in the companies it writes about, or a combination of the two. For full disclosure, please visit: https://www.cannabisfn.com/legal-disclaimer/. A short time after we acquire the securities of the foregoing company, we may publish the (favorable) information about the issuer referenced above advising others, including you, to purchase; and while doing so, we may sell the securities we acquired. In addition, a third-party shareholder compensating us may sell his or her shares of the issuer while we are publishing favorable information about the issuer. Except for the historical information presented herein, matters discussed in this article contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time to time have a position in the securities mentioned herein and will increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity- based compensation in the companies it writes about, or a combination of the two. For full disclosure please visit: https://www.cannabisfn.com/legal-disclaimer/.

Copyright © Accelerize Inc. · All Rights Reserved · Privacy Policy · Legal Disclaimer

loading