InhaleRx (ASX:IRX) executed a study order with iNGENū CRO as the contract research organization to oversee a phase two clinical trial of its non-opioid inhaled Breakthrough Cancer Pain management alternative candidate IRX-211 for opioid-tolerant patients, according to a Thursday Australian bourse filing.
The phase two double-blind, placebo-controlled, multicenter trial will evaluate the efficacy, safety, and tolerability of IRX-211.
Breakthrough Cancer Pain is characterized by high-intensity, short-duration pain that occurs often in several episodes per day.
The trial is fully funded by a facility of up to AU$38.5 million with Clendon Biotech Capital.
It plans to file an amendment with the Human Research Ethics Committee to accommodate the new sample size and will likely consult with the US Food and Drugs Administration on the changes associated with this amendment.
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