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Pivot Pharma Looks to Improve Cannabinoid Bioavailability with Topical BiPhasix™ Delivery System

Ryan Allway

September 19th, 2017

News, Top Story

The global medical cannabis industry is expected to exceed $55 billion in annual sales by 2025, according to Grand View Research, driven by liberal drug laws and increasing interest among consumers, academics and healthcare providers. Early research has shown that cannabinoids, like tetrahydrocannabinol (THC) and cannabidiol (CBD), could treat many medical conditions ranging from chronic pain to childhood epilepsy.

A major problem with cannabinoid-based therapeutics is the lack of a robust delivery mechanism. In a 2009 study, researchers found that the bioavailability varied from 2-56% for inhaled cannabis smoke to 4-20% for oral consumption. The absorption of inhaled cannabinoids tended to vary widely between individuals, while the oral consumption of cannabinoids was degraded in the stomach and subject to first-pass metabolism in the liver. In addition, smoking may not be appealing to patients for health or lifestyle reasons. Topical delivery is an alternative but current topical cannabinoid preparations suffer from many formulation issues such as weak or inert creams and poor absorption, and they are often not very consumer friendly (e.g. greasy or oily).

Transdermal cannabinoid delivery could provide a great alternative route of administration since it reduces the negative side-effects associated with inhaled dosing and bypasses first-pass metabolism in the liver. In addition, transdermal delivery enables patients to access a steady stream of medication over a prolonged period of time rather than experiencing only acute effects.

Pivot Pharma Acquires BiPhasix™

Pivot Pharmaceuticals Inc. (OTCQB: PVOTF) recognized the benefits of transdermal cannabinoid delivery and acquired worldwide rights to BiPhasix™ Transdermal Drug Delivery technology for the delivery of cannabinoids. The company’s newly created subsidiary, Pivot Green Stream Health Solutions Inc. (“Pivot Green Stream”), will focus on improving bioavailability of cannabinoid-based nutraceuticals and pharmaceuticals, including treatments for female sexual dysfunction and psoriasis.

“I am pleased to lead Pivot as we continue to develop therapeutic pharmaceuticals and nutraceuticals as well as drug delivery platforms,” said Interim CEO Patrick Frankham, PhD, MBA, in a recent press release announcing the new delivery system. “BiPhasix™ is a disruptive technology that will revolutionize how medical cannabinoids are administered.”

BiPhasix™ has been tested in FDA and EMA approved human clinical trials, which have shown that it can significantly enhance the bioavailability of many drugs and improve clinical outcomes. In addition, the delivery system can serve as an alternative dosage form to injectables by providing less invasive routes of administration, such as dermal, transdermal, nasal, vaginal, ocular, and rectal.

Lead Product Candidates

PGS-N005 (Female Sexual Dysfunction CBD Topical Cream)

Using BiPhasix™ platform technology, Pivot Green Stream will initiate development of a topical cream containing CBD (“PGS-N005”) for perimenopausal, menopausal and post-menopausal women who have noticed a decline in sexual desire and response, known as hypoactive sexual desire disorder (HSDD). Up to 63% of sexually active women in the U.S. might be affected by female sexual dysfunction (“FSD”). While erectile dysfunction in men has been extensively researched, very little has been completed on FSD which can involve reduced sex drive, difficulty becoming aroused, vaginal dryness, lack of orgasm and decreased sexual satisfaction. The FSD market in the U.S. is estimated to exceed $4 billion with over 50 million potential sufferers.

PGS-N007 (Psoriasis BiPhasix™ CBD Topical Cream)

The psoriasis market is set to rise from $6.6 billion in 2014 to over $13.3 billion by 2024 at a compound annual growth rate of 7.3 percent. According to the National Psoriasis Foundation, psoriasis affects 7.5 million people in the United States. According to Global Data and the World Health Organization, the reported prevalence of psoriasis in countries ranges between 0.09% and 11.4%, making psoriasis a serious global problem with at least 100 million individuals affected worldwide.

Research has shown that CBD has potent anti-inflammatory properties suggesting that cannabinoids may be helpful for inflammation-related skin conditions like psoriasis and eczema. CBD, THC and other cannabinoids are anti-psoriasis agents. Under a psoriasis condition, skin cells are replaced every three to five days rather than the normal 30 days. This excessive and rapid growth of the epidermal layer of the skin generates red, itchy and scaly patches, which may be localized or completely cover the body. PGS-N007 will aim to treat psoriasis.  

These products (PGS-N005, PGS-N007) will be registered as ‘natural health products’ for consumers, which enables a shorter development cycle and faster revenue generation opportunities than traditional pharmaceuticals that tend to be much more expensive and time-consuming to develop through extensive clinical trials.

Looking Ahead

Pivot Pharmaceuticals Inc. (OTCQB: PVOTF) represents a compelling opportunity in the biotechnology space. In addition to its promising pharmaceutical technology pipeline, Pivot has recently acquired a new transdermal delivery technology that it plans on immediately applying to develop cannabinoid based products resulting in a Health Canada Natural Health Product (NHP) designation. Pivot has positioned itself in a growing and crucial vertical in the cannabinoid industry and will work with Licensed Producers (LP) and Licensed Dealers (LD) to bring newer therapies to patients.

Investors may want to keep a close eye on the stock, particularly as it has applied to list on the Canadian Stock Exchange (CSE) which opens up a large new investor market.

For more information, please visit the company’s website.

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.

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