Silo Pharma Announces Successful Production of its SP-26 Ketamine Implant for Fibromyalgia
Silo Pharma announced the successful production of its SP-26 ketamine implant designed for fibromyalgia and chronic pain. Analytical testing confirmed optimal formulation, with pre-clinical research ongoing. Small batch proof-of-concept extrusion trials for 20% and 40% ketamine hydrochloride loads showed validation in structural stability and integrity. Manufacturing studies using three bioresorbable polymers revealed positive data for inherent viscosity, blend uniformity, and dissolution, meeting FDA guidelines. CEO Eric Weisblum stated that these findings bring Silo closer to future pre-clinical testing models, highlighting the implant's promising structural stability and functionality.
- Successful production of SP-26 ketamine implant for fibromyalgia and chronic pain.
- Optimal formulation confirmed through analytical testing.
- Validation of delivery system in pre-clinical research.
- Positive assay testing results for inherent viscosity and blend uniformity.
- Sample results met FDA guidelines for blending levels.
- Larger implants showed faster dissolution time.
- CEO highlighted promising structural stability and functionality.
- Pre-clinical stage, no guarantee of future success.
- No specific timeline for clinical trials provided.
- Potential risks of delays in future testing phases.
- Financial implications of ongoing research not disclosed.
Insights
The recent announcement from Silo Pharma about their SP-26 ketamine implant for fibromyalgia and chronic pain is significant. The company’s pre-clinical study has shown promising results in terms of drug delivery system stability and integrity. This is important because it indicates the formulation is on the right path towards efficacy and safety, which are pivotal in getting regulatory approval.
Ketamine, traditionally used as an anesthetic, has gained attention for its potential in chronic pain management and psychiatric disorders. The advantage of using a bioresorbable polymer for delivery is that it allows for a controlled release of the active ingredient, potentially reducing side effects compared to conventional administration routes.
The mention of the implants meeting FDA guidelines in terms of blending and dissolution times is particularly noteworthy. This indicates that the implant not only works in theory but also adheres to strict regulatory standards, a critical step for any new therapeutic device.
For retail investors, the positive pre-clinical results are an encouraging sign that the company is making strides toward a viable product, although the path to market approval is still lengthy and fraught with risks.
From a market perspective, Silo Pharma’s development of the SP-26 ketamine implant could position the company strongly within the chronic pain management industry, which is substantial and poised for growth. The emphasis on non-opioid treatments is particularly relevant given the ongoing opioid crisis and the increasing demand for alternative pain management therapies.
The chronic pain market is estimated to be worth billions, with fibromyalgia alone impacting millions of people globally. Innovating within this space with a successful product could significantly boost Silo Pharma’s market share and revenue prospects.
However, investors should be aware of the competition in this sector. Several companies are exploring similar non-opioid pain management solutions and Silo Pharma will need to continuously demonstrate superior efficacy and safety to gain a competitive edge. The successful pre-clinical results are only the first step in a lengthy process of regulatory approval and market acceptance.
Analytical testing has confirmed optimal formulation for upcoming studies
SARASOTA, FL, June 07, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced a successful series of development activities for the Company’s SP-26 ketamine implant therapeutic targeting fibromyalgia and chronic pain.
An ongoing pre-clinical research study of SP-26 is underway involving analytical testing services and small batch proof-of-concept extrusion trials for the ketamine hydrochloride (ketamine HCL) implants at
The Company previously reported that the initial testing provided validation of the delivery system based on measures of structural stability and integrity at both load levels. Following those tests, a series of manufacturing studies were conducted using three different bioresorbable polymers. The assay testing revealed positive data for inherent viscosity (IV), blend uniformity (BU), and dissolution of the implants:
- IV results were within the expected range for drug delivery of the active ingredient, and higher for the combined formulation with ketamine
- The sample results met FDA guidelines for an adequate level of blending
- The larger implants showed faster dissolution time
Silo CEO, Eric Weisblum commented, “The results so far in our ongoing SP-26 pre-clinical research bring us closer to determining the optimal formulation for future pre-clinical testing models. We are pleased with the structural stability, integrity, and functionality observed to date for our innovative non-opioid chronic pain therapeutic.”
About SP-26
Silo’s SP-26 is a ketamine-based injectable dissolvable implant for the treatment of chronic pain and fibromyalgia. The subcutaneous implant is being designed to safely regulate dosage and time release of the pain-relieving treatment. If clinically successful, SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval.
About Silo Pharma
Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company developing novel therapeutics that address underserved conditions including stress-induced psychiatric disorders, chronic pain conditions, and central nervous system (CNS) diseases. Silo focuses on developing traditional therapies and psychedelic treatments in novel formulations and drug delivery systems. The Company’s lead program, SPC-15, is an intranasal treatment targeting PTSD and stress-induced anxiety disorders. SP-26 is a time-release ketamine-loaded implant for fibromyalgia and chronic pain relief. Silo’s two preclinical programs are SPC-14, an intranasal compound for the treatment of Alzheimer’s disease, and SPU-16, a CNS-homing peptide targeting multiple sclerosis (MS). Silo’s research and development programs are conducted through collaborations with Columbia University and the University of Maryland, Baltimore. For more information, visit www.silopharma.com and connect on social media at LinkedIn, X, and Facebook.
Forward-Looking Statements
This news release contains "forward-looking statements" within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential”, and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events, or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.
Contact
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FAQ
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