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Oxford, UK – Glide Technologies, the pharmaceutical development and device company focused on solid dose formulations of therapeutics and vaccines, today announced that it has initiated a clinical proof-of-concept study comparing its novel solid formulation of octreotide acetate with the currently marketed liquid product (Sandostatin®). Octreotide is approved for use in the treatment of acromegaly and certain neuroendocrine tumours, with the estimated market for immediate release liquid formulations exceeding $150 million.
The clinical study will compare the pharmacokinetic profile and bioavailability of the most widely used dose of Sandostatin (100 mcg) with Glide’s octreotide solid dose formulation delivered via the company’s novel needle-free solid dose injection system (SDI®). Glide’s SDI® provides the potential for room temperature stable products and improved patient-friendly self-administration. The study is ongoing in the UK following approval from the Medicines and Healthcare products Regulatory Agency, and the results are expected in Q3 2016.
Dr Mark Carnegie-Brown, Glide Technologies’ CEO, commented, “This clinical trial represents a significant milestone, providing Glide the opportunity to demonstrate both bioequivalence with the currently marketed Sandostatin® liquid product and the utility and patient acceptance of the SDI® delivery system. The clinical study builds on the highly encouraging pre-clinical data we have achieved with our octreotide, teriparatide and exenatide solid dose formulations, and we look forward to reporting the results in the coming months.”