Pharmather eyes commercialization of Parkinson’s ketamine treatment
FDA sets Aug. 9 decision date for medication to be branded as Ketarx
Pharmather is advancing its ketamine-based treatment for Parkinson’s disease as the approval decision date of Aug. 9, 2025, set by the U.S. Food and Drug Administration (FDA) draws closer.
If approved, the company plans to market the product under the brand name Ketarx and expand its use in neurological conditions, including Parkinson’s, where ketamine’s potential to ease symptoms such as tremors and dyskinesia, or involuntary movements, is being actively explored.
“Receiving an approval goal date from the FDA provides a clear line of sight to potential approval and commercialization for our ketamine product,” Fabio Chianelli, Pharmather CEO, said in a company press release.
The company has submitted investigational new drug (IND) applications and pre-INDs for ketamine indications including Parkinson’s and other neurological conditions, as well as for novel delivery systems such as an on-body wearable pump and microneedle patch.
Pharmather has established a manufacturing strategy based in the U.S. to avoid potential supply chain disruptions. With this process in place, the company will be ready to scale up to commercial production if it receives approval. The company is fully funded through the goal approval date and its potential U.S. commercial launch, according to the press release.
“Our primary focus between now and [Aug.] 9, 2025, is executing on our pre-commercial strategy,” Chianelli said. “We have the team, the capital, and the plan in place to deliver on our commitment.” The company is also getting ready to apply for approval in other countries, including in Europe, the UK, Canada, Japan, and parts of the Asia-Pacific region, with plans to start in the second half of this year.
Clinical trial shows ketamine reduced dyskinesia induced by levodopa
Parkinson’s is a neurodegenerative disease caused by the death of nerve cells that produce the signaling molecule dopamine. This can lead to a variety of motor symptoms, including tremors and difficulty walking, as well as nonmotor symptoms.
One of the main treatments for Parkinson’s disease is levodopa, a medication that provides the body with a building block needed to make dopamine. By helping the brain produce more dopamine, levodopa and similar drugs can reduce motor symptoms like tremors and stiffness. However, after long-term use of levodopa, many people with Parkinson’s may develop dyskinesia. Low doses of ketamine may help reduce these involuntary movements, according to studies in rat models and Parkinson’s patients.
Current FDA approvals cover ketamine for pain relief and anesthesia. Pharmather doesn’t expect the doses used for Parkinson’s to induce anesthesia.
A Phase 2 clinical trial (NCT04912115), sponsored by the company, demonstrated that ketamine reduced dyskinesia induced by levodopa. Similarly, all participants in a separate Phase 1/2 trial showed reduction in dyskinesia. The medication was also well tolerated.
Growing U.S. legislative support for investigations of ketamine and other psychedelic-based medications has encouraged Pharmather to broaden its plans for commercialization, according to the press release.
“We are building a global ketamine pharmaceutical franchise,” Chianelli said. “The upcoming FDA approval goal date is our beachhead. From there, we will expand globally and into new indications, driven by science and a commitment to patients.”
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