PharmaTher Holdings enters collaboration to commercialize racemic ketamine

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) plans to submit an abbreviated new drug application (ANDA) for KETARX, a racemic ketamine product.

The submission to the U.S. Food and Drug Administration (FDA) is slated for early July, announced the company on Tuesday.

PharmaTher is optimistic about receiving FDA approval for KETARX by the first quarter of 2024. If all goes according to plan, the company expects to commercially launch the product by the second quarter of the same year.

In preparation for the potential launch, PharmaTher is joining forces with Vitruvias. The two companies will collaborate on a range of pre-launch activities. These include developing marketing strategies, setting pricing, planning distribution, managing care, establishing trade relations and creating sales plans.

This development is a significant step forward in the field of ketamine-based treatments. More updates will follow as the situation progresses.

“Our highest priority is to obtain regulatory approvals and commercialize KETARX (racemic ketamine) worldwide for unmet medical needs,” PharmaTher CEO Fabio Chianelli said.

“We are focused on building a network of strong commercial partnerships with leading specialty generic companies that are experienced in the marketing, sales and distribution to the hospital, institutional and clinic channels within their territories.”

“We are pleased to partner with Vitruvias for KETARX for the U.S. market and believe Vitruvias is the ideal partner to rapidly progress our commercialization goals in the U.S. and unlock new commercial opportunities internationally,” Chianelli said.

Read more: Psycheceutical Bioscience develops non-psychoactive ketamine topical for PTSD and depression

Read more: Silo Pharma to develop ketamine implant for fibromyalgia and chronic pain

PharmaTher, in collaboration with Vitruvias, is set to market KETARX under the FDA-approved label for ketamine. The product will be offered in a variety of dosage forms to cater to different patient needs. These include concentrations of 10 milligrams per milliliter (mg/ml), 50 mg/ml and 100 mg/ml. This range allows for flexibility in dosage administration based on the specific requirements of each patient.

Moreover, there is an option to increase the concentration beyond these levels, providing a versatile solution for various medical applications. The product will also be available in ready-to-administer formats, making it convenient for use in the U.S. market.

At present, ketamine is included on the FDA’s drug shortage list, indicating a higher demand than supply for this medication. Despite this, it is being used in hospitals and clinics beyond its FDA-approved indications.

Medical professionals are administering ketamine to treat a wide array of disorders such as depression and anxiety, neurological disorders like chronic migraines and various types of pain.

“The evolving adoption of ketamine for its current FDA approved use, and potentially other indications excite us on the opportunity to grow the market for ketamine in the U.S., leveraging our strong commercial expertise and infrastructure,” Vitruvias CEO Carl L. Whatley said in a statement.

Read more: Silo Pharma prepares pre-IND package for FDA on novel ketamine formulation

Read more: EntheoTech Bioscience opens flagship ketamine clinic in Kelowna

S and R Ketamine, the same but different

Ketamine, a powerful anesthetic and potential antidepressant, exists in two enantiomeric forms: R-ketamine and S-ketamine. These enantiomers, while structurally similar, exhibit distinct effects in medical applications.

S-ketamine, also known as esketamine, is often associated with more potent anesthetic properties and has been approved by the FDA for treatment-resistant depression in adults. It is known for its rapid antidepressant effects but can cause side effects like potential addiction, dissociation, dizziness and nausea.

On the other hand, R-ketamine, or arketamine, is reported to have longer-lasting antidepressant effects than S-ketamine and fewer side effects. It is not yet FDA-approved, but ongoing research indicates that it may be a more potent and longer-acting antidepressant compared to S-ketamine.

In clinical settings, a racemic mixture of both R and S ketamine is commonly used, which has been found to produce a rapid and robust antidepressant effect within hours of treatment. However, the specific effects of each enantiomer are still being studied to tailor treatments more effectively.

In the rapidly evolving field of psychedelic therapeutics, two companies, Psycheceutical Bioscience Inc (OTC: BWVI) and Silo Pharma, Inc. (Nasdaq: SILO) are making significant strides in harnessing the potential of ketamine for novel treatment methods.

Psycheceutical Bioscience announced last week it has developed a ketamine topical that provides therapeutic benefits of the psychedelic without complications from the drug’s psychoactive effects when administered in other ways.

Silo Pharma announced this month it is set to research and develop a ketamine implant to help treat fibromyalgia and chronic pain. The company said that the implant will have a specific dosage and time-release mechanism for the treatment. The research efforts will also include analytical testing services and small-scale pre-clinical extrusion trials to assess drug release and stability.

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The post PharmaTher Holdings enters collaboration to commercialize racemic ketamine appeared first on Mugglehead Magazine.

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