On April 5th, Zalicus realized that enrolling patients receiving pain meds prior to screening visit rather than excluding them was a good idea because these patients are in pain. Before this time, they were selecting against these folks.
Explains why Justin Renz is not hip on the PHN trial. Sounds like they screwed it up and just now made the correction to enroll patients in pain who will benefit form Z160.
The question is, how many "no pain" patients have they enrolled already that will have no efficacy results for Z
I now concur with Garrett and Justin Renz that our best hope is the Lumbosacral Radiculopathy trial. I hope it comes off first.
The Postherpetic Neuralgia trial inclusion criteria based on the pain scale initially excluded those taking analgesics and opioids. Now Zalicus is backtracking to include these people. This means they enrolled people with high pain tolerance or lower pain as defined by the fact that they were not taking meds.
Understand? They changed the criteria.
Allergan's criteria for their PHN trial was as follows:
Allergan PHN Inclusion Criteria:
Persistent postherpetic neuralgia (PHN) with nerve pain present for at least 9 months after onset of herpes zoster skin rash.
Allergan PHN Exclusion Criteria:
Female patients with reproductive potential
Active herpes zoster skin rash
Current or anticipated treatment with acupuncture, TNS (nerve stimulation), or steroids
Current or anticipated use of topical analgesic agents with PHN
Treatment with botulinum toxin therapy of any serotype within the prior 12 weeks
It is ok if you do not agree, but the PHN trial might not make it due to a spectrum of complications with pain scale, pain tolerance, and treatment confounding effects.