Aeterna Zentaris Inc. (AEZS, AEZ.TO) entered into an agreement with the Food and Drug Administration or FDA on a Special Protocol Assessment or SPA for Solorel, which would enable the company to complete the ongoing registration study required to gain approval as a diagnostic test for Adult Growth Hormone Deficiency or AGHD.
The study was initiated to compare the performance of Solorel against the then-available diagnostic growth hormone releasing hormone or GHRH Geref Diagnostic + Arginine standard test. GHRH Geref Diagnostic was subsequently withdrawn from the market, worldwide, in 2008.
Juergen Engel, Ph.D., President and CEO at Aeterna Zentaris said, "In line with our innovative approach, Solorel could become the first approved oral test for the diagnosis of AGHD, providing patients with a potentially safer, accurate and more convenient alternative to the current injectable tests."
The completed part of the study was a two-way crossover study, and included 42 patients with confirmed AGHD or multiple pituitary hormone deficiencies and a low insulin-like growth factor-I.
As a secondary endpoint, the protocol would require that at least 8 of the 10 newly enrolled AGHD patients be correctly classified by a pre-specified peak Growth Hormone threshold level, the company added.
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