I don't know if the FDA requires 2 phase III trials of all drugs. I have seen many drugs approved with only one phase 3 trial.
In this case with Sophiris, you are correct however. This from the company:
"A 7.60 point improvement in IPSS total score over 12 months indicates that patients are experiencing a significant relief of their BPH symptoms and improvement in their quality of life following a single treatment with PRX302," said Dr. Allison Hulme, chief operating officer and head of research and development at Sophiris Bio. "Oral medications such as alpha blockers and 5-alpha reductase inhibitors typically demonstrate a 3-6 point improvement in IPSS total score. We believe that a statistically significant improvement in IPSS, if replicated in a second Phase 3 trial, may be sufficient for registration with the FDA."
Where I had been confused was the improvement of the IPSS score. Upon reading the study results more closely, the improvement of 7.6 has to be compared to the vehicle-only control of 6.58. So ultimately 1.02 improvement compared to control.
However, in the quote paragraph above, the company states that typical drugs such as alpha blockers ad 5-alpha reductase inhibitors only produce an improvement in IPSS scores of 3 to 6 points.
Ultimately it will require a second phase III. Since results of the last phase III came out a year ago, I am concerned as to the length of time elapsed and they have not started or even formulated a second phase III. Any info on that would be appreciated.
So to add to the speculation, is the delay strictly related to the company looking for an investment, partner, or buyout?
