OXFORD, England, June 28, 2016 /PRNewswire/ - Glide Technologies today announced results from a successful clinical proof-of-concept study that demonstrated its novel solid formulation of the most widely-used dose of octreotide (100 mcg) achieved bioequivalence to the currently marketed immediate release liquid injectable product (Sandostatin®). Glide's formulation was delivered using the company's proprietary needle-free Solid Dose Injector (SDI®), which provides the potential for room temperature stability and patient-friendly administration. 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 compared the tolerability, pharmacokinetics and bioavailability of 100 mcg of Sandostatin® delivered by needle and syringe with Glide's octreotide solid dose formulation delivered via SDI®. The results demonstrate that Glide's formulation achieved bioequivalence, matching Sandostatin® on both maximum peak concentration (Cmax) and area under the curve (AUC). In addition, the study subjects (n=20) confirmed the suitability of the SDI® for self-administration and reported an overwhelming preference for the Glide SDI® over needle and syringe. The Glide delivery system was well tolerated by the subjects who rated injection comfort as 4.45 on a scale of 0-5 (with 5 being most comfortable).
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