Results

29% of all patients (722 of 2499) enrolled reported symptom improvement at 3 months*^‡

61% of patients (722 of 1192) who continued treatment for 3 months experienced improvement in symptoms^†‡

In a separate, double-blind, randomized, placebo-controlled study, 38% of patients taking ELMIRON^® 300 mg/day reported at 3 months a greater than 50% improvement in bladder pain compared with 18% of patients taking placebo (N=151).^§

Symptom improvement may be gradual

Clinical response may require 3 to 6 months of continuous therapy

^*2499 patients received at least 1 dose of ELMIRON^®.
^†1192 of 2499 patients received ELMIRON^® treatment for 3 months.
^‡Pain scores that improved by 1 or 2 categories.
^§N=128 patients in 300-mg/day group. Patient's Overall Rating of Improvement of Symptoms (PORIS) response is based on all patients, not completers.

IMPORTANT SAFETY INFORMATION

Contraindications: ELMIRON^® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.
Anticoagulant Activity: ELMIRON^®is a weak anticoagulant which may increase bleeding. Rectal hemorrhage was reported as an adverse event in 6.3% of patients. Patients undergoing invasive procedures or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to other therapies such as coumarin anticoagulants, heparin, t-PA, streptokinase, high dose aspirin, or nonsteroidal anti-inflammatory drugs) should be evaluated for hemorrhage. Patients with diseases such as aneurysms, thrombocytopenia, hemophilia, gastrointestinal ulcerations, polyps, or diverticula should be carefully evaluated before starting ELMIRON^®.
Heparin-Induced Thrombocytopenia: Caution should be exercised when using ELMIRON^® in patients who have a history of heparin-induced thrombocytopenia.
Alopecia: In clinical trials of ELMIRON^®, 97% of the cases of alopecia reported were alopecia areata, limited to a single area on the scalp.
Hepatic Insufficiency: ELMIRON^® has not been studied in patients with hepatic insufficiency. Because there is evidence of hepatic contribution to the elimination of ELMIRON^®, hepatic impairment may have an impact on the pharmacokinetics of ELMIRON^®. Caution should be exercised when using ELMIRON^® in this patient population.
Information for Patients: Patients should take the drug as prescribed, in the dosage prescribed, and no more frequently than prescribed. Patients should be reminded that ELMIRON^® has a weak anticoagulant effect. This effect may increase bleeding times.
Pregnancy and Lactation: Adequate and well-controlled studies have not been performed in pregnant women. Because animal studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed. It is not known if ELMIRON^® is excreted in human milk. Caution should be exercised when ELMIRON^® is administered to a nursing woman.
Most Common Adverse Reactions (frequency 1% to 4%): Alopecia (4%), diarrhea (4%), nausea (4%), headache (3%), rash (3%), dyspepsia (2%), abdominal pain (2%), liver function abnormalities (1%), and dizziness (1%).

cp-59277v1

Proven Efficacy

Study Design

Results

Symptom improvement may be gradual

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

ELMIRON^® is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.

INDICATION