Just weeks after the FDA required more data prior to approving an oral form of Octreotide, proposed by Chiasma Pharmaceuticals, a British pharmaceutical and device company, Glide (not the dental floss), is initiating a clinical trial of a needle free injection system that implants a solid dose of Octreotide under the skin.
Glides injection device known as SDI (Solid Dose Injector) won the “Best Business” Award at the Medical Futures Innovation Awards in 2007. The clinical trial is hoping to show that the product is stable at room temperature and easy to self administer, as well as biologically equivalent and effective.
The liquid formulation known as Sandostatin, is currently used for acromegaly as well as some neuroendocrine tumors. The medication will be produced in Glasgow Scotland by Albany Molecular Research. The clinical trial is expected to enroll approximately 20 patients with this rare disorder.
However, a similar clinical trial in the US failed to gain FDA approval despite the overwhelming support of the clinical trial patients. The trial was sponsored by Endo Pharmaceuticals and involved an 84-MG Octreotide Subcutaneous Hydrogel implant in subjects with acromegaly.
One patient from the US trial told Patient Worthy,
” I literally went into a depression when I learned that the solid dose was not going to be available to me. For two years, while on the clinical trial, I had enjoyed a quality of life that I had not known was possible and which, I had never known before. I had no breakthrough symptoms because I had a dependable dose every day. The medication was an implant under my skin every six months- and it worked! The trouble with the monthly injections is that you get breakthrough symptoms for about 7 days before your next dose is due. When it was not approved I felt my quality of life was being ripped from me. That is also why I was so very disappointed when Chiasma’s medication was also not approved. I have signed a petition asking the FDA to reconsider their decision. They do not understand how much breakthrough symptoms affect the lives of patients with Acromegaly, and a daily pill would be a blessing, because we would get the same dose every day. The status quo is not good enough.”
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