Acquisition Has Love Pharma’s Naltrexone on NIH Shortlist to Address Unmet Medical Need—Treatment for Long Covid

Love Pharma Inc. (CSE: LUV) (FSE: G1Q0), an international mental health and sexual wellness company, has been explicit about it plans to develop a portfolio of innovative products encompassing transdermal drug delivery applications in the addiction space, and a recent non-binding letter of intent to acquire Naltrexone Therapeutics Inc., would immediately bolster the company’s footprint in that space.  At the same time, Naltrexone Therapeutics, a pharmaceutical company with significant Intellectual Property (IP) related to the transdermal delivery of the well-known FDA-approved drug “Naltrexone,” could potentially expand Love Pharma’s reach into additional therapeutics and land the company at the leading edge of addressing an unmet medical need.

When completed, it’s an acquisition that would add a promising application for the treatment of post-COVID conditions or “long COVID” to Love Pharma’s portfolio.1  Long COVID is a condition that can include a wide range of ongoing health problems, including fatigue, shortness of breath, insomnia, joint pain and memory loss, which according to the Centers for Disease Control and Prevention (CDC), can last weeks, months, or even longer.  Currently, there is no treatment for the lasting symptoms of COVID-19, so it’s a clear unmet medical need in a large and growing patient population.

The significance of the deal is the considerable IP that Love Pharma would gain related to the transdermal delivery of Naltrexone.  Why is this significant?  Well, Naltrexone is approved to treat opioid and alcohol addiction at 50 milligrams per dose.  However, the drug has shown promise at very low doses as a potential treatment that can reverse some of the underlying pathology that is driving symptoms related to long COVID.1  And while several generic manufacturers sell the 50 milligram pills, low-dose Naltrexone must be acquired through a compounding pharmacy, which makes it more difficult to access and limits the drug’s availability.

Enter Love Pharma and the transdermal drug delivery IP it would own in a Naltrexone Therapeutics acquisition.  The company’s transdermal delivery IP could offer a patient friendly, low-dose delivery solution that can be made readily available to patients.  If low-dose Naltrexone continues to show promise in studies for long COVID,1 a transdermal patch would be the solution to delivering the drug in a low-dose formulation perfected in studies.

Love Pharma’s Chief Executive Officer (CEO), Zachary Stadnyk, commenting on the benefits of transdermal drug delivery said, “Transdermal delivery can provide patients with a convenient, safe, and regulated dosage of Naltrexone that allows for greater bioavailability, steady absorption, ease of use, and fewer gastrointestinal tract (GI)-related side effects that are common with oral dosages currently available, the latter of which we believe has the potential to expand the market for Naltrexone.”

Globally more than 40% of COVID-19 survivors currently have or have had long-term effects after recovering from the virus, according to a new study by researchers at the University of Michigan.  Today, the World Health Organization reports that there have been 628,035,553 COVID infections worldwide, so based on estimates from a report produced by the National Library of Medicine which states, “up to 37.7% of COVID patients experience symptoms beyond 12 weeks after infection,”2 we can extrapolate that there is a significant market need for treatment(s).  In the United States alone, the CDC reports that nearly 1 in 5 American adults, who have had COVID-19, also dealt with long COVID.

To combat this unmet medical need, the U.S. government is taking steps to fund more research and help those affected by long COVID, including the National Institutes of Health (NIH) that launched the $1.15 billion “Researching COVID to Enhance Recovery” or “RECOVER” Initiative.

Acquiring Naltrexone Therapeutics should be regarded as blockbuster news for both Love Pharma and its investors given the NIH has short-listed Naltrexone as one such treatment to be tested under the RECOVER Initiative.1  In addition to being on the NIH’s short list, there are also four clinical trials to test Naltrexone in hundreds of long COVID patients currently planned.1

Love Pharma obviously recognizes the potential opportunity that producing and delivering tens of millions of transdermal patches could offer the company should a low-dose treatment prove successful.  So, Love Pharma’s CEO initiated a deal that would allow his company to get directly involved with Naltrexone just as the drug is at the forefront of research to uncover the underlying causes and develop treatments for long COVID alongside industry names like Pfizer.

According to Love Pharma, this is how a transdermal drug delivery solution works:

— The transdermal formulation of a drug can be incorporated within a patch, which is then applied to the skin surface of the patient

— A transdermal patch provides a consistent absorption rate over a predetermined time as prescribed. The delivery method for transdermal drug delivery of suitable drugs can be highly flexible and can be applied for periods such as 24, 48, 72, 96, 120, and 144 hours – and up to 7, 8, 13, 14 or 15 days

— Transdermal delivery overcomes the challenge of multiple dosage regimens associated with oral applications and accurately reflects the proper dosage entering the patient’s system to address the symptoms, while also circumventing the GI tract and related side effects

And let’s not forget the strategic alliance that Love Pharma established less than two months ago with Starton Therapeutics, a leading US clinical-stage biotechnology company.  Starton has a proprietary continuous drug delivery technology that can improve efficacy of approved drugs, make them more tolerable, and expand their potential use.

Love Pharma stated that its investment in Starton Therapeutics is primarily based upon “the company’s interest in innovative drug delivery technology, such as transdermal patches that can reduce side effects, transforming patient outcomes with established, approved medicines allowing for streamlined market entry with long-term IP protections.”

Each piece of the company’s strategic plan is beginning to become more clear.  Acquiring Naltrexone Therapeutics and its significant IP related to the transdermal delivery of Naltrexone and any subsequent development of a treatment for long COVID using Naltrexone could certainly benefit from Starton’s three different delivery technologies that provide continuous low-dose delivery as part of its strategic platform that provides a controlled, sustained release over multiple days.

1 https://www.reuters.com/business/healthcare-pharmaceuticals/addiction-drug-shows-promise-lifting-long-covid-brain-fog-fatigue-2022-10-18/

2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9250701/

To learn more about Love Pharma, visit https://love-pharma.com or email investors@love-pharma.com.

About Love Pharma Inc.

With a focus on the global sexual Health and Wellness markets, Love Pharma Inc. was founded in 2020, with a mission to bring to market innovative products that enhance sexual health and wellness while providing an improved quality of life.  Love Pharma holds exclusive licenses to produce, market, package, sell, and distribute patent-protected therapeutic and pharmaceutical products throughout Europe, the United Kingdom, and North America.

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