Silo Pharma’s SP-26 Ketamine Implant Demonstrates Successful Drug Delivery
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The update on SP-26, a novel time-released formulation of ketamine being developed by Silo Pharma, signals a significant advancement in the treatment of chronic pain conditions such as fibromyalgia. The successful encapsulation of ketamine within the implant suggests a potential breakthrough in implantable drug delivery systems (IDDS). Unlike traditional oral or injectable drugs that can cause fluctuations in drug concentration levels, IDDS are designed to maintain a consistent therapeutic window. This could mean a more stable management of symptoms for patients, potentially reducing the frequency of doses and minimizing side effects associated with peak concentrations.
Moreover, the structural stability of the implants is crucial for their viability as a long-term treatment option. The absence of leakage, degradation, or discoloration in pre-clinical trials is a positive indicator of the product's integrity over time. If SP-26 progresses successfully through clinical trials and gains regulatory approval, it could be a game-changer in pain management, offering a new, longer-lasting treatment option for patients with chronic pain conditions.
From a financial perspective, Silo Pharma's progress with SP-26 could have a notable impact on the company's valuation and future revenue streams. The chronic pain management market is a multi-billion-dollar industry and the introduction of an effective implantable treatment could capture a significant market share. The successful development of SP-26 could lead to increased investor confidence, potentially driving up Silo's stock price.
However, it's important to consider that Silo Pharma is still in the developmental stage and the path to commercialization includes rigorous clinical trials and regulatory hurdles. While the pre-clinical research findings are promising, investors should weigh the risks associated with the lengthy and uncertain process of drug development. The financial implications will largely depend on the company's ability to continue to report positive results, secure necessary funding for further development and navigate the FDA approval process effectively.
The development of SP-26 also has implications for the medical device sector, particularly in the area of drug delivery systems. The technology behind IDDS is complex and requires a multidisciplinary approach to ensure both efficacy and safety. The pre-clinical results indicate that Silo Pharma is potentially on track to create a device that can reliably administer medication over a prolonged period, which could disrupt traditional pain management practices.
It's also worth noting that advancements in IDDS, such as the one Silo Pharma is working on, could pave the way for further innovation in the field. This could include new applications for other chronic conditions that require consistent drug delivery. The success of such technology could stimulate investment and research in this sector, potentially leading to a broader range of treatment options and a new generation of medical devices.
Initial indications target fibromyalgia and chronic pain
Loaded and encapsulated drug maintains structural stability as implantable treatment
SARASOTA, FL, Feb. 14, 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 provided a positive update on SP-26, its novel time-released, dose-controlled formulation of ketamine initially targeted for fibromyalgia. A pre-clinical research study is underway involving analytical testing services and small batch proof-of-concept extrusion trials to determine drug release and stability.
In recent testing, SP-26 polymer implants were blended with ketamine hydrochloride (ketamine HCL) in two loadings,
“Implantable drug delivery systems like SP-26 may provide sustained drug delivery for prolonged periods of time, which is critical for the treatment of chronic pain conditions,” said Eric Weisblum, CEO of Silo. “We believe the initial testing provided sufficient validation of the delivery system for SP-26 and accordingly, our focus has shifted to testing of the ketamine formulation to measure drug dissolution and time-release action.”
Mr. Weisblum noted that conventional oral and injectable drugs typically provide peaks of concentration in blood followed by diminished concentration that falls outside of the therapeutic window. Silo believes that implantable drug delivery systems (IDDS) can offer a superior delivery alternative for sustained relief from chronic pain.
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.
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.
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FAQ
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