Pharmather to seek FDA guidance for ketamine study in Parkinson’s
Trial would test Ketarx's ability to ease involuntary movements in patients
Pharmather is planning to meet with the U.S. Food and Drug Administration (FDA) in hopes of reaching an agreement on the design of a future Phase 3 clinical trial testing its generic ketamine product Ketarx in individuals with Parkinson’s disease.
The plans were mentioned in a company press release announcing recent regulatory and financial developments that may allow Pharmather to advance its ketamine-based programs — previously focused on pain management — to additional indications such as Parkinson’s.
Ketarx, Pharmather’s generic formulation of Ketalar (ketamine hydrochloride), was approved by the FDA in August for use in surgical pain management. Generic versions have the same active ingredient as the brand-name product, as well as comparable strength, routes of delivery, safety, effectiveness, and intended uses. Generics usually come at a significantly lower cost, however.
The company last week also announced the sale of Ketarx’s abbreviated new drug application (ANDA), which had been submitted to the FDA to seek approval in the U.S. market alone for the generic product.
This means that the therapy’s commercialization rights in the U.S. were transferred to another company, whose name was not disclosed at this time for business reasons. This sale could generate up to $25 million in income for Pharmather over the coming years, the release stated.
“Our investment in developing the ketamine ANDA was a strategic move, designed not only for near-term monetization but also to establish a long-term foundation for our proprietary ketamine pipeline,” said Fabio Chianelli, CEO of Pharmather. “The sale of the ketamine ANDA allows us to capitalize on the generic injectable ketamine market while simultaneously advancing our proprietary ketamine-based programs into larger market opportunities.”
In Parkinson’s, the death of nerve cells that produce the signaling molecule dopamine causes disruptions in brain signaling. As a result, people with Parkinson’s may develop motor symptoms, such as tremors and difficulty moving, as well as nonmotor symptoms.
Levodopa, a medication that supplies a key building block of dopamine, is the mainstay of Parkinson’s treatment. It allows the brain to produce more dopamine, potentially normalizing signaling and easing motor symptoms. However, long-term use of levodopa or similar therapies can lead to side effects, including involuntary movements known as dyskinesia.
Ketarx, ketamine generic, was well-tolerated in earlier Parkinson’s trial
Ketamine is a pain-relieving medication that is approved as a surgical anesthetic. Previous studies in rodent models and people with Parkinson’s — including a Pharmather-sponsored Phase 2 clinical trial (NCT04912115) — have suggested that low-dose, subanesthetic ketamine may help treat levodopa-related dyskinesia.
In the U.S.-based Phase 2 study, 30 adults with Parkinson’s and levodopa-related dyskinesia received intravenous, or into-the-vein, infusions of either low-dose ketamine or the sedative midazolam, delivered over about two months.
The results showed that low-dose ketamine safely and effectively reduced dyskinesia. Participants generally tolerated the therapy well, and all reported side effects were mild or moderate.
The future Phase 3 trial in Parkinson’s is intended to have an adaptive design, meaning that modifications to the trial and/or statistical procedures can be applied after the study’s start without undermining its validity and integrity.
Pharmather said it is looking for a pharmaceutical partner to advance Ketarx’s development for Parkinson’s.
In addition, the company plans to advance its clinical programs in complex regional pain syndrome and amyotrophic lateral sclerosis. Pharmather is also developing new ketamine delivery systems, such as an on-body wearable pump and a ketamine patch, which could allow for easy and controlled delivery of the medication.
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