Stage 3 trails start in IND
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Stage 3 trails start in IND
by Tee Sat Feb 11, 2012 10:18 pm
03 February 2012
OptiNose, a drug delivery company, has filed an investigational new drug (IND) with the FDA to use sumatriptan delivered with its novel drug delivery technology, in December 2011.
The review has been completed and the FDA has notified the company to proceed with the studies related to IND.
The company is expected to initiate Phase III trials in adults with acute migraine with or without aura utilizing its novel intranasal technology.
OptiNose CEO Peter Miller said the filing signals an important milestone in their quest to deliver improved relief to patients who suffer from migraine headaches.
"Based on our clinical study results to date, we are encouraged by the potential of the OptiNose technology," Miller added.
OptiNose, a drug delivery company, has filed an investigational new drug (IND) with the FDA to use sumatriptan delivered with its novel drug delivery technology, in December 2011.
The review has been completed and the FDA has notified the company to proceed with the studies related to IND.
The company is expected to initiate Phase III trials in adults with acute migraine with or without aura utilizing its novel intranasal technology.
OptiNose CEO Peter Miller said the filing signals an important milestone in their quest to deliver improved relief to patients who suffer from migraine headaches.
"Based on our clinical study results to date, we are encouraged by the potential of the OptiNose technology," Miller added.
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