-The company did not conduct the clinical trials the way that the FDA would have wanted them done. The studies were combined to show statistical significance.
-The company met statistical significance on only one of the three endpoints even though the one was the most important in that it demonstrated efficacy (NPRS score).
-Addressing a 30 min application (new) where the FDA might want to see more clinical data before granting approval.
-HIV-PHN Trials with Qutenza have not shown consistency in replicating superiority results vs. placebo.
Pros into Adv Panel:
-The company addressed an unmet clinical need by addressing HIV-PHN pain for which there is no approved FDA therapy.
-The company did meet statistical significance in efficacy (NPRS scale) by achieving a (.002) statistical significance.
-Almost met statistical significance in terms of the response (.0051).
-Transient mild to moderate pain at the site is consistent with the AE’s using Qutenza for in PHN. Additionally, as Qutenza is a topical treatment with minimal systemic absorption, it is expected to have minimal risk of drug-drug interactions, a feature that is particularly important in this patient population.
IN PHN Studies…In clinical trials, serious adverse reactions included application-associated pain and increase in blood pressure. The most common treatment-emergent adverse reactions (greater than or equal to 5 percent of Qutenza patients and greater than control) were application-site erythema, application-site pain, application-site pruritus, and application-site papules."
"A very strong chance that there is a positive advisory panel in my opinion. The fact that this is an sNDA and not an NDA also helps as the drug has already been on the market for over a year in the U.S. and Europe. If there were any glaring red flags in the risk associated with the use of Qutenza then those would have already been identified. The fact that this sNDA was given priority review leads me to believe that this drug needs to be used in an extended population (HIV) so that there is a therapy brought to a condition to which there is no approved FDA therapy & clearly meets an unmet need. Qutenza used in this condition could be the very thing that Neurogesx needs to grow sales of this product. The need is demonstrated in that the drug has Orphan Drug, Fast Track, & Priority Review for this sNDA. Advisory Board Mtng is on Feb 9th. "
Agree in your point of view. And it is important to anlyse all the positive and teh negative points.
Qutenza(R) (capsaicin) 8% Patch for HIV-Associated Peripheral Neuropathy (HIV-PN)this has "Priority Review", FDA Priority Review status is given to drug candidates that offer significant advances in treatment, or provide a treatment where no adequate therapy exists, and accelerates the standard review time from 10 months to six months, wich is the case. And note that NGX-4010 efficacy was superior to placebo regardless of sex, baseline pain score, or duration of neuropathy.