Ketamine News: PharmaTher Begins FDA Filing For KETARX Application, Stella Acquires Field Trip Assets

Specialty biotech company PharmaTher Holdings Ltd. PHRRF has filed a pre-submission facility correspondence in advance of its Abbreviated New Drug Application (ANDA) for its novel racemic ketamine KETARX to the FDA.

The filing of the pre-submission correspondence is expected to help achieve an expedited review of the company’s ANDA, compared to the standard approval times. 

PharmaTher anticipates KETARX approval to come sometime within 2024’s first quarter and U.S. commercial launch in the second quarter, closely followed by the pursuit of international approvals to support ketamine’s growing global demand for anesthesia and analgesia, as well as the treatment of mental health disorders including depression, anxiety and suicidal ideation.

The company’s stated priority is to commercialize KETARX in the U.S. under ketamine’s FDA-approved label through its new partnership with generic pharma company Vitruvias Therapeutics Inc., offering various dosage forms with the option to increase concentration and ready-to-administer applications.

PharmaTher is also commercializing its microneedle PharmaPatch through several partnerships with psychedelics-developing companies.

Stella Expands Trauma Care Offering With Field Trip Assets’ Buy

Mental healthcare treatment provider Stella has acquired ketamine company Field Trip’s FTHWF U.S. assets -see Reunion Neuroscience’s recent take-private transaction announcement- toward broadening its treatments offering and becoming “a comprehensive provider of holistic, effective biological and psychological treatments.”

The announcement follows a May-dated $7 million funding round toward further clinical research and expanding Stella’s clinic model from a network-based approach to operating its own facilities. 

To date, Stella’s therapies are offered across 35 U.S. locations, as well as in Israel and Australia. 

The company’s Dual Sympathetic Reset (DSR) protocol is an advanced Stellate Ganglion Block (SGB) procedure designed specifically to treat Post Traumatic Stress Injury (PTSI) and was first introduced by its CMO Dr. Eugene Lipov in 2006. 

Stella currently offers ketamine protocols through treatments such as its Special Operation Forces Protocol combining ketamine with DSR for the treatment of high-risk brain injury. 

The acquisition will have Stella assume operations of Field Trip clinics in New York and Washington D.C., expanding the geographical reach of the DSR protocol. 

Additionally, the company is opening a new treatment clinic in Irvine, California which is joining the also new one in Chicago, Illinois.

Incoming Field Trip advanced outcome data, research, technology stack and clinics will help Stella offer cutting-edge digital psychedelic therapies offerings along with its existing services.

Former Field Trip’s founder and president Mujeeb Jafferi and CTO Amardeep Manhas will join Stella’s leadership team as president and clinics operation officer and chief technology officer respectively.

Photo: Benzinga edit with photo by PopTika and luchschenF on Shutterstock.