Biopharmaceutical Company Announces Successful Fibromyalgia Implant Production
Silo Pharma Announces Successful Production of SP-26 Ketamine Implant for Fibromyalgia.
Disclaimer: The information provided in this article is based on the latest available data as of June 2024. It is intended for educational and informational purposes only and should not be construed as medical advice or an endorsement. Always consult a healthcare professional before starting any new treatment or therapy.
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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, has recently announced successful development activities for its SP-26 ketamine implant therapeutic targeting fibromyalgia and chronic pain. This announcement marks a significant milestone in the Company’s quest to provide innovative solutions for chronic pain management.
Overview of SP-26 Development
The SP-26 project centers around creating a ketamine-based injectable dissolvable implant designed specifically for the treatment of chronic pain and fibromyalgia. The objective is to develop a subcutaneous implant that can safely regulate dosage and release time of the pain-relieving treatment. Ketamine, traditionally known for its anesthetic properties, has been found to have potent effects in treating certain types of chronic pain when administered correctly.
Pre-Clinical Research and Testing: The ongoing pre-clinical research study includes extensive analytical testing services and small batch proof-of-concept extrusion trials for the ketamine hydrochloride (ketamine HCL) implants, which come at 20% and 40% drug load concentrations. These studies are crucial for validating the efficacy and safety of the SP-26 formulation. Silo Pharma had previously reported promising initial testing results that validated the delivery system’s structural stability and integrity at both 20% and 40% drug loads. These findings were foundational in moving forward with further manufacturing studies, which aimed to refine the formulation and ensure consistent performance. A series of manufacturing studies ensued, utilizing three different bioresorbable polymers to determine the most effective formulation for delivering ketamine. The assays performed during these studies revealed critical insights:
Inherent Viscosity (IV): The IV results were within the expected range for drug delivery of the active ingredient, and higher for the combined formulation with ketamine. This indicates that the formulation maintains its desired properties when ketamine is included.
Blend Uniformity (BU): The sample results met FDA guidelines for an adequate level of blending. Consistent blend uniformity is essential for ensuring each implant delivers the correct therapeutic dose.
Dissolution Time: The larger implants exhibited faster dissolution times, which is beneficial for controlled release and managing the onset of therapeutic effects.
These positive results suggest that the SP-26 implants have the potential to provide a reliable and effective means of delivering ketamine for chronic pain management.
Future Steps
According to Silo CEO Eric Weisblum, “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.” These advancements signify a step forward in developing non-opioid pain management options, which is a critical need given the ongoing opioid crisis.
SP-26 functions as a subcutaneous implant designed to administer ketamine over a controlled period. The primary advantage of this delivery method is its ability to maintain steady plasma levels of the drug, thereby avoiding the peaks and troughs associated with traditional administration methods. This controlled release mechanism is particularly advantageous for managing chronic conditions such as fibromyalgia, where consistent pain relief is essential.
Non-Opioid Alternative: With the current opioid epidemic, there is a significant demand for alternative pain management therapies. SP-26 offers a promising solution by utilizing ketamine, which has a different mechanism of action compared to opioids and is less likely to lead to dependence.
Controlled Release: The implant's ability to regulate the release of ketamine ensures that the patient receives a consistent therapeutic dose, potentially improving the effectiveness of the treatment and reducing side effects.
Enhanced Patient Compliance: As a dissolvable implant, SP-26 eliminates the need for frequent dosing, which can improve patient compliance and overall treatment outcomes.
Challenges and Considerations
While the initial results are promising, several challenges remain. The transition from pre-clinical testing to clinical trials involves rigorous scrutiny to ensure safety and efficacy in human subjects. Additionally, long-term studies are necessary to understand the full impact of the treatment, including any potential side effects or complications arising from chronic use. If clinically successful, SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval. This pathway can expedite the approval process by allowing the Company to leverage existing data on ketamine, thus potentially bringing the product to market more quickly.
Silo Pharma’s successful production and initial testing of the SP-26 ketamine implant marks a significant advancement in the field of chronic pain management. The promising pre-clinical results highlight the potential of this innovative therapeutic to provide a safer, non-opioid alternative for patients suffering from fibromyalgia and other forms of chronic pain.
The ongoing research and development efforts underscore Silo Pharma’s commitment to pioneering novel drug delivery systems that enhance patient care. As SP-26 progresses through the development pipeline, it holds the promise of becoming a valuable addition to the arsenal of treatments available for chronic pain.
Disclaimer: The information provided in this article is based on the latest available data as of June 2024. It is intended for educational and informational purposes only and should not be construed as medical advice or an endorsement. Always consult a healthcare professional before starting any new treatment or therapy.
As an investor it's important to stay updated with major news. Get real-time stock market alerts, news, and research by creating an account here.