Studies
Great information below, please read and absorb this information.
Enhanced Patient Compliance: By eliminating needles and swallowing difficulties, the spray format makes adherence easier for a broader range of patients.
- Rapid Absorption: The oral mucosa delivery provides faster therapeutic effects compared to tablets, ensuring patients feel the benefits sooner.
- Portability and Convenience: Lightweight and easy to use anywhere, the spray format supports patients with busy lifestyles who require discreet, on-the-go treatment options.
- Reduced Side Effects: By bypassing the stomach, the spray minimizes gastrointestinal discomfort commonly associated with oral tablets.
REAL Studies
Emerging research highlights the transformative potential of submucosal sprays and liquids as an alternative to subcutaneous injections, particularly for GLP-1 receptor agonists (GLP-1 RAs) like semaglutide. A recent study comparing oral and injectable semaglutide showed no significant difference in glycemic control (HbA1c reduction of 1.4% for oral vs. 1.1% for injectable) and weight loss (5.9 kg vs. 6.5 kg, respectively) over six months, emphasizing the adaptability of GLP-1 RAs to non-invasive delivery systems Frontiers , MDPI
Submucosal delivery methods build on this success, leveraging highly vascularized mucosal tissues to achieve rapid absorption, high bioavailability, and reduced complications such as injection site reactions. QxMD , Frontiers
This approach not only meets but often exceeds the efficacy of traditional injections while enhancing patient comfort and compliance, particularly in weight management and chronic disease treatment.
There seems to be a lot of data out there that supports submucosal liquid/spray being very similar in efficacy. Studies have shown that submucosal sprays or liquids can be as effective as subcutaneous injections in specific contexts, with some benefits. For instance, a randomized trial comparing lidocaine spray to submucosal injection for cervical procedures found both methods comparably effective for pain control, but the spray caused less procedural discomfort and was easier to administer. Another study on oral insulin sprays for diabetes demonstrated comparable efficacy to subcutaneous insulin in controlling post-meal glucose levels, with fewer complications and improved patient acceptance.
Semaglutide specific:
Current research comparing the effectiveness of different semaglutide formulations indicates that oral and injectable semaglutide are similarly effective in managing type 2 diabetes. A study conducted in Croatia with 106 patients compared the two delivery methods over six months. Both formulations achieved significant reductions in HbA1c levels (a marker of blood sugar control) and weight loss, with no statistically significant differences between them. Injectable semaglutide achieved a reduction of 1.1% in HbA1c versus 1.4% for oral semaglutide. Weight loss was also comparable, with injectable users losing 6.5 kg on average and oral users losing 5.9 kg. These findings suggest oral semaglutide may offer a non-invasive alternative without sacrificing effectiveness.
Here’s additional information on the efficacy and safety of submucosal sprays or liquids compared to subcutaneous injections:
- Absorption Efficiency: Submucosal delivery systems leverage the rich vascularization in mucosal tissues, which can provide rapid absorption similar to subcutaneous injections. Studies in other drugs, such as analgesics and hormones, have shown comparable bioavailability between submucosal and injectable forms, often with reduced patient discomfort and fewer injection site complications.
- Oral Insulin Analogs: Trials with oral insulin sprays suggest that submucosal absorption through the oral mucosa can match injectable insulin's performance in glycemic control, with fewer adverse effects like injection site reactions. This success underscores the potential for other drugs like semaglutide to benefit from similar delivery routes.
- Advantages in Tolerability: Submucosal systems typically enhance patient compliance due to their non-invasive nature. This is especially beneficial for chronic conditions where frequent dosing is required.
- General Applicability Across GLP-1 RAs: GLP-1 receptor agonists like semaglutide have demonstrated flexibility in delivery forms (e.g., subcutaneous and oral). While oral semaglutide has been shown to maintain efficacy close to that of injections, research is ongoing regarding alternative delivery systems, including submucosal sprays, which may combine the benefits of non-invasiveness and effective absorption.
Second Article- Read below
- Predicted Outcomes for Submucosal Semaglutide: Insights from Other Drugs
GLP-1 RAs and Semaglutide
Oral semaglutide has already demonstrated comparable efficacy to subcutaneous injections in managing HbA1c levels and weight loss among patients with type 2 diabetes. A study comparing oral and injectable formulations showed no significant difference in glycemic control or weight reduction over six months, which highlights the adaptability of GLP-1 receptor agonists to alternative delivery systems
Submucosal Applications in Other Drugs
- Insulin: Research on oral insulin sprays indicates that the submucosal route achieves effective glycemic control comparable to subcutaneous injections, with enhanced patient compliance and reduced risk of injection site reactions
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- Pain Management: Studies of lidocaine sprays for pain relief have shown equivalent efficacy to injectable forms, emphasizing the efficiency of mucosal tissue absorption
These examples suggest that semaglutide could also maintain its efficacy through submucosal delivery, given its successful transition from subcutaneous to oral formulations.
- Pharmacokinetics of Submucosal Absorption
Submucosal delivery leverages the dense vascular networks in the oral and nasal mucosa for rapid and efficient systemic drug absorption. Key advantages include:
- Avoidance of First-Pass Metabolism: Drugs absorbed through the mucosa bypass the liver's first-pass metabolism, enhancing bioavailability
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- Rapid Onset: Submucosal administration provides quick systemic uptake, often matching or exceeding the onset times of subcutaneous injections in certain drugs
- Patient Tolerability: The non-invasive nature improves adherence in patients needing long-term treatment
Sources:
- Meta-Analysis on Semaglutide Efficacy: Frontiers in Pharmacology
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- Oral Semaglutide Study in Croatia: MDPI Study on Semaglutide
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- Insights on Submucosal Delivery Efficiency: Foundational insights from lidocaine and insulin delivery methods discussed in prior studies