Fibromyalgia Care Breakthrough: DEA Green Lights Biotech Partnership Exploring Ketamine Implant Therapy

Silo Pharma’s (NASDAQ: SILO) novel ketamine-loaded implant targeting fibromyalgia and chronic pain conditions, SP-26, is reportedly advancing through analytical testing and preclinical trials toward determining drug release and stability following approval by state and federal authorities. 

The psychedelics biotech has partnered with Sever Pharma Solutions for development and manufacturing. The implant’s design, including dosage and time-release delivery, aims to become an at-home pain relief treatment.

“Many chronic pain sufferers are seeking a non-opioid treatment that offers relief. Based on findings to date, we believe SP-26 has the potential to be the first at-home approved ketamine treatment for chronic pain including fibromyalgia,” said CEO Eric Weisblum.

See Also: Hope For Fibromyalgia Sufferers, Cannabis Linked To Improved Symptoms & Less Opioid Use In UK Study

Following recent compliance inspections, Florida state and the DEA greenlighted Sever Pharma to begin working with ketamine and loading it into the new implant. 

Assessing the dosage and time-release implant formulation through subcutaneous (SQ) injection, the ongoing early preclinical research will focus on the drug’s safety profile facing requirements from the Food and Drug Administration (FDA) for potential designation as an at-home therapeutic. 

Silo stated its intentions of pursuing the agency’s streamlined 505(b)(2) pathway for SP-26’s approval.

See Also: PharmaTher's Novel Ketamine Heads For The US Market With New Collaboration Agreement

Some estimates valued the fibromyalgia market at nearly $3.1 billion in 2022 with a projected growth marked by a compound annual growth rate of 4% in 2032. Meanwhile, others project the broader chronic pain market will exceed $140 billion by 2030.

See Also: Silo Pharma, Mindset Pharma, Terran Biosciences Receive Psychedelic Treatments Patents, IP Portfolios Expanded

Photo courtesy of Karolina Grabowska on Pexels.