Psychedelics Company Silo Pharma Working On Time-Release And Dosage Ketamine Implant And Topical, Hoping To Deliver Steady Pain Relief For Four Million Fibromyalgia Sufferers

This month, Silo Pharma SILO announced a new research and development agreement to create a time-release ketamine implant to treat fibromyalgia and other chronic pain conditions. The development-stage biopharma company has a portfolio of therapies in its pipeline that merge traditional therapeutics with the latest psychedelic research in its pipeline. 

Silo is aiming to leverage its existing partnerships with academic research institutions to help move this novel treatment for chronic pain sufferers through the Food and Drug Administration’s approval process as efficiently as possible. The fibromyalgia market grew to $3.1 billion last year and is projected to keep growing at a compound annual growth rate of 4% over the next decade. Meanwhile, the larger chronic pain market is forecast to exceed $140 billion by 2030, with many chronic pain sufferers in desperate need of a treatment that delivers powerful pain relief without the serious side effects or risk of addiction that come with opioids. 

Time-Release Implants Put Ketamine’s Pain-Relieving Potential In A More Practical Delivery Format

For the estimated four million Americans with fibromyalgia, the chronic condition causes episodes of widespread pain throughout the body that have no specific cause. While the causes aren’t yet clear, researchers believe the pain is rooted in the central nervous system, where disordered pain receptors become over-excited or dysregulated. 

Ketamine blocks the activity of the N-methyl-D-aspartate receptor (NMDAR), which is thought to play a role in amplifying pain signals sent to the brain from pain sensors around the body. In a systematic review of studies on intravenous ketamine infusions for patients with fibromyalgia, researchers found consistent evidence that the drug could relieve pain. But all studies faced a key challenge: the pain relief was short-term, wearing off a few hours after the infusion. 

For consistent pain management, patients would need frequent ketamine infusions for the duration of a flare-up, which can last anywhere from a few days to a few weeks. That’s why Silo is working on a time-release implant. An implant that could deliver a steady, low dose of ketamine would be a more viable alternative to repeated visits to a clinic to receive IV infusions. 

Silo Has Already Made Progress On A Time-Release Topical Treatment Using Ketamine

The development agreement for the implant comes just months after Silo announced positive preclinical results for SP-26, a topical ketamine treatment the biopharma company is also developing for chronic pain conditions, with fibromyalgia as the initial indication.

In March, Silo announced results from a preclinical study involving mini pigs that demonstrated SP-26 was safe and well-tolerated. The drug candidate uses Zylo Therapeutics’ Z-pod technology to package ketamine in tiny silica particles that allow the developers to better control the dosage and release of the pain-relieving treatment. 

Preclinical efficacy studies are already underway for the novel topical ketamine treatment, with data expected in September or October of this year. Those results should help bolster Silo’s application to begin human trials under the Food and Drug Administration’s streamlined 505(b)(2) pathway. The streamlined pathway is intended for treatments where published research on the treatment’s safety or efficacy already exists. 

There is already a growing body of research on potential therapeutic uses of ketamine, and the FDA has already approved other ketamine-based therapies, including Johnson & Johnson’s JNJ ketamine-derived nasal spray, Spravato. That existing groundwork of research could help Silo fast-track its clinical research to get this novel pain-relieving treatment to market as soon as possible.

Featured photo by Karolina Grabowska on Pexels.

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