Inspire Pharmaceuticals Announces Results in Perennial Allergic Rhinitis Trial
DURHAM, N.C., May 20 /PRNewswire-FirstCall/ -- Inspire Pharmaceuticals, Inc. (Nasdaq: ISPH - News) today announced results of a large, multicenter trial of INS37217 Intranasal in patients with perennial allergic rhinitis (PAR). The trial was a randomized, parallel-group, double-blind, placebo-controlled study designed to assess the safety and efficacy of INS37217 Intranasal in a 10mg/mL non-preserved nasal spray formulation. The 28-day study was conducted in 630 patients at 24 centers across the United States.
In this study, INS37217 Intranasal was well tolerated but did not meet the primary endpoint of significantly reducing the total nasal symptom score over the 28-day treatment period versus placebo. The total nasal symptom score was a composite of four symptoms: rhinorrhea (runny nose), nasal congestion, nasal itching and post-nasal drip. The reduction in symptoms for INS37217 Intranasal was less than that seen in the previously reported Phase I and II studies in PAR and common cold.
Although the primary endpoint was not met, patients receiving INS37217 Intranasal had a decreased incidence of respiratory-related infection as compared to patients on placebo. This finding will require further evaluation. The Company is conducting various secondary analyses and is planning an experts' meeting to review the study data in detail and determine potential next steps for the program.
"While INS37217 Intranasal continued to demonstrate a strong safety profile, it did not perform as expected in this PAR trial, compared to consistent positive results seen in previous Phase I and II trials," stated Christy L. Shaffer, Ph.D., Inspire CEO. "We will continue to conduct secondary analyses to determine future plans for the intranasal program."
Inspire will host a conference call today at 10:00 am EDT. Participants in the United States can access the call by dialing 800-657-1269. Participants outside the United States may call 973-935-2100. The call will be webcast from Inspire's website at www.inspirepharm.com. |
