PharmaTher's recent news

The manufacturer of ketamine products, PharmaTher Holdings Ltd., has had a lot of things going on this past week. Here are the top three news items of the company.

The FDA granted an orphan drug designation to the company's proprietary racemic ketamine KETARX for the treatment of the rare genetic neurological disorder Rett Syndrome.

Ketamine has been tested in Phase 2 of a clinical trial for Rett syndrome, of which unpublished results will be used to support a potential Phase 3 clinical study and get approval from the FDA via the 505 b 2 regulatory pathway.

The new designation adds to four others held by PharmaTher onKETARX, for the prevention of Ischemia-reperfusion injury from organ transplantation, the treatment of Status Epilepticus and Amyotrophic Lateral Sclerosis ALS, as well as complex regional pain syndrome.

PharmaTher submitted an FDA meeting package to discuss its Phase 3 program and fast-track designation for KETARX in Parkinson's disease.

Phase 3 development would target the company's proprietary ketamine as a treatment for levodopa-induced dyskinesia in Parkinson's disease LID-PD If results were positive, they would support a new drug application under the 505 b 2 regulatory pathway for KETARX in treating this specific condition.

The company asked for FDA guidance on obtaining Fast Track Designation for KETARX, a response that the company expects to receive by March 20, 2023.

PharmaTher expects the case to be supported by the results from its completed clinical study, which includes safe, well-tolerated and reduction in dyskinesias from baseline in participants - all with moderate to advanced Parkinson s - specifically 51% reduction during infusion 2, 49% at 3 weeks and 41% at 3 months post-ketamine.

On the same topic, PharmaTher is retaining the rights to a US patent covering compositions and methods for treating motor disorders, including ketamine in the potential treatment of Parkinson's and motor disorders that cause involuntary or uncontrollable movement or actions of the body.

A Partnership On MDMA Delivery With Novel Transdermal Patch

PharmaTher entered into a research collaboration agreement with the Revive Therapeutics Corp. RVVTF to evaluate MDMA delivery through the company's novel microneedle patch delivery technology.

The results from PharmaTher's completed non-clinical study assessing its MDMA microneedle patch will be available in the first half of 2023 and will be used to support a potential human clinical study.

Partners will develop a product and clinical development plan to initiate regulatory discussions for future clinical studies in various indications of MDMA, including depression, anxiety, abuse disorders, and PTSD.

Revive s CEO Michael Frank explained that this test will complement the company's therapeutic psilocybin programs, which include a Phase 1 - clinical study for meth use disorder, developing a novel psilocybin oral thin film strip and developing a biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform.

Based on novel biocompatible and biodegradable gelatin methacryloyl material delivery to deliver water-soluble and insoluble drugs, the new patch is expected to enable flexible drug load capacity and combinations, and be able to present desired pharmacokinetic PK and safety profiles, potentially overcoming obstacles of oral dosing.

Photo: Benzinga edit with photo by DyrElena by Shutterstock and Wikimedia Commons.