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Additional Relevant Details Additional relevant topics discussed included the proposed use of maximum daily pain as a primary endpoint for registration, which DBRUP indicated would be potentially acceptable, subject to consultation with the Division of Anesthesia, Analgesia and Addiction Products upon receipt of a final protocol. Discussion on secondary endpoints was consistent with the company's expectations. Importantly, Aquinox shared with the FDA final audited analysis of the secondary endpoint of urinary frequency from the LEADERSHIP trial demonstrating a statistically significant reduction in urinary frequency with AQX-1125, compared to placebo (p = 0.04) after determining that the previous unaudited analysis had not been normalized for assessing frequency over a 24 hour periods. Both Aquinox and the FDA agreed that improvement in urinary frequency, in addition to reduction in pain, would be an important endpoint in assessing the benefit of AQX-1125 to BPS/IC patients. Aquinox also announced today that it has recently completed a clinical trial demonstrating bioequivalence between AQX-1125 capsules and tablets. All future clinical development will utilize AQX-1125 tablets. Aquinox is also planning to seek Scientific Advice from the European Medicines Agency in the first half of 2016 on topics similar to those discussed with the FDA.

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