Silo Pharma and Partner Receive Regulatory Approval to Begin Development of Ketamine Implant for Fibromyalgia

Rhea-AI Summary

Silo Pharma, Inc. (Nasdaq: SILO) is developing a potential at-home pain relief treatment for fibromyalgia and other chronic pain conditions. The company's dosage and time-release ketamine-loaded implant, designated as SP-26, is advancing through analytical testing and small batch pre-clinical proof of concept extrusion trials in collaboration with Sever Pharma Solutions. The implant formulation will be studied utilizing the subcutaneous injection method, with Silo intending to pursue the FDA’s streamlined 505(b)(2) pathway for approval of SP-26.

Insights

Pharmaceutical Research Analyst

The development of SP-26, Silo Pharma's ketamine-loaded implant, represents a significant innovation in the field of pain management, particularly as it pertains to non-opioid treatments. The focus on a time-release formula for at-home administration could potentially address a significant unmet need in chronic pain management. The use of the 505(b)(2) regulatory pathway suggests a strategic approach to expedite the approval process by relying on existing safety and efficacy data from previously approved drugs. This could result in a shorter development timeline and reduced costs.

From a market perspective, the fibromyalgia treatment market, valued at $3.1 billion and the broader chronic pain market, projected to exceed $140 billion by 2030, indicate substantial commercial potential for SP-26. The successful development and approval of this treatment could provide Silo Pharma with a strong market position, given the demand for non-opioid alternatives.

However, the development of drug-loaded implants carries inherent risks, including potential adverse reactions and the challenge of ensuring consistent drug release rates. Furthermore, the regulatory landscape for psychedelics and their derivatives is complex and any shifts in policy could impact the approval process for SP-26. Investors should monitor the progress of pre-clinical trials and any emerging data on the safety and efficacy of the implant.

Financial Analyst

The announcement of Silo Pharma's progress with SP-26 could influence investor sentiment, as it signals advancement towards a potentially lucrative market. The mention of positive compliance inspections and the ability to work with ketamine legally provides a level of regulatory assurance that is critical for investor confidence. Additionally, the decision to pursue the 505(b)(2) pathway can be financially beneficial, as it may lead to quicker market entry and lower development costs compared to the traditional drug approval route.

Investors should evaluate the potential impact of SP-26 on Silo Pharma's revenue streams and growth prospects. Given the size of the chronic pain management market and the projected growth rates, a successful launch of SP-26 could significantly enhance Silo's financial position. It's also important to consider the competitive landscape and any existing or upcoming treatments that could affect SP-26's market share.

While the potential for high returns exists, investors must also weigh the risks associated with the developmental stage of the company and the uncertainty of clinical trial outcomes. The capital required for continued development and potential commercialization will also be a key factor in assessing Silo Pharma's financial health and future funding needs.

Market Research Analyst

The chronic pain management sector presents a growing market opportunity, as evidenced by the projected market valuations. The unique selling proposition of SP-26 lies in its at-home application and non-opioid nature, which aligns with current trends in patient-centric and opioid-sparing therapies. The shift towards treatments that patients can administer themselves is a reflection of broader trends in healthcare towards convenience and autonomy.

Understanding the patient population for fibromyalgia and chronic pain conditions is crucial for forecasting the adoption rate of SP-26. Factors such as ease of use, efficacy, side effects and cost will all play a role in patient acceptance and market penetration. If SP-26 proves to be a viable alternative to opioid medications, it could capture a significant share of the market, especially given the current opioid epidemic and the medical community's interest in finding safer pain management options.

Market research should continue to monitor patient and physician awareness and perception of ketamine-based treatments. The success of SP-26 will depend not only on its clinical performance but also on the marketing strategies employed to educate and promote the treatment to both healthcare providers and patients.

Silo dosage and time-release formulation aim for potential first at-home Ketamine therapeutic

SARASOTA, FL, Dec. 28, 2023 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or “the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today announced an update on its dosage and time-release ketamine-loaded implant, designated as SP-26, which is being developed as a potential at-home pain relief treatment for fibromyalgia and other chronic pain conditions. In collaboration with Sever Pharma Solutions, Silo’s contract development and manufacturing partner, SP-26 is advancing through analytical testing and small batch pre-clinical proof of concept extrusion trials to determine drug release and stability.

Following recent positive compliance inspections from the state and federal Drug Enforcement Administration (DEA) authorities, Sever Pharma Solutions now has the required approval from such state and federal DEA authorities to commence working with ketamine and loading it into the implant. The dosage and time-release implant formulation will be studied utilizing the subcutaneous injection method.

Early preclinical research will focus on the drug’s safety profile with respect to the FDA’s requirements for potential designation as an at-home therapeutic. Silo intends to pursue the FDA’s streamlined 505(b)(2) pathway for approval of SP-26.

Eric Weisblum, Chief Executive Officer of Silo Pharma, commented “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.”

The expanding fibromyalgia market was valued at approximately $3.1 billion in 2022 and is projected to grow at a compound annual growth rate of 4% over the next decade.¹ The broader chronic pain market is projected to exceed $140 billion by 2030.²

About Silo Pharma 

Silo Pharma Inc. is a development-stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as PTSD, Alzheimer’s disease, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the healthcare industry. For more information visit www.silopharma.com

Forward-Looking Statements 

All statements other than statements of historical fact in this announcement are forward-looking statements that involve known and unknown risks and uncertainties and are based on current expectations and projections about future events and financial trends that the Company believes may affect its financial condition, results of operations, business strategy, and financial needs. Investors can identify these forward-looking statements by words or phrases such as "may," "will," "expect," "anticipate," "aim," "estimate," "intend," "plan," "believe," "potential," "continue," "is/are likely to" or other similar expressions. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in the Company's filings with the SEC.

Contact 

800-705-0120 
investors@silopharma.com

1 Allied Market Research: Fibromyalgia Treatment Market Research, 2032
² Spherical Insights: Global Chronic Pain Market Size…, 2023  

FAQ

What is the company name and ticker symbol for the developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research?

The company is Silo Pharma, Inc. and its ticker symbol is SILO.

What is the potential at-home pain relief treatment being developed by Silo Pharma, Inc.?

Silo Pharma is developing a dosage and time-release ketamine-loaded implant, designated as SP-26, for fibromyalgia and other chronic pain conditions.

Who is Silo Pharma, Inc.'s contract development and manufacturing partner for the SP-26 implant?

Silo Pharma's partner for the SP-26 implant is Sever Pharma Solutions.

What is the FDA pathway that Silo Pharma, Inc. intends to pursue for approval of SP-26?

Silo Pharma intends to pursue the FDA’s streamlined 505(b)(2) pathway for approval of SP-26.

What is the projected value of the expanding fibromyalgia market and the broader chronic pain market?

The expanding fibromyalgia market was valued at approximately $3.1 billion in 2022 and is projected to grow at a compound annual growth rate of 4% over the next decade. The broader chronic pain market is projected to exceed $140 billion by 2030.