Pharmacology
Iloprost Inhalation Solution : A Non-Invasive Alternative to Treat Pulmonary Arterial Hypertension
By Akanksha, Pharmacology Correspondent
Mar 23, 2005, 11:44

CoTherix, Inc. announced today the commercial availability of Ventavis� (iloprost) Inhalation Solution in the U.S. for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in patients with NYHA Class III or IV symptoms. PAH is a progressive, highly debilitating and potentially fatal disease characterized by high blood pressure in the pulmonary arteries.

"Now that iloprost is broadly available in the U.S., patients can receive the benefits of a prostacyclin without the needles and catheters associated with the infused prostacyclin treatments," said Donald J. Santel, Chief Executive Officer of CoTherix, Inc. "We're pleased to deliver this important therapy to the PAH community ahead of our formal launch in early April."

Santel added, "Based on the positive results from our STEP trial evaluating the combination of iloprost added to Tracleer therapy, we believe there is an opportunity for iloprost to be used early in the course of the disease."

"As part of our launch plan for iloprost, we have activated a sales force of 23 highly trained individuals, established a hotline to assist physicians and patients in attaining reimbursement, and secured ample drug to meet the anticipated initial patient demand. We believe we have all the components in place to serve this important market," said Thomas L. Feldman, President and Chief Business Officer of CoTherix, Inc. "It's extremely encouraging to see that third-party payers are approving reimbursement for iloprost and prescriptions have been filled."

Iloprost Inhalation Solution was approved by the U.S. Food and Drug Administration (FDA) on December 29, 2004 for the treatment of PAH (WHO Group I) in patients with NYHA Class III or IV symptoms. Iloprost is the newest entry into the prostacyclin class of PAH treatments.

Prior to the introduction of iloprost, prostacyclin therapies for PAH required continuous delivery through subcutaneous or intravenous routes -- invasive treatments which are difficult to tolerate and/or require complicated maintenance.

Now, with iloprost, PAH patients can benefit from a non-invasive, inhaled treatment option. In recently released results from the STEP clinical study, the addition of iloprost to Tracleer� (bosentan) therapy provided statistically significant improvements in several key clinical parameters.

Iloprost is currently marketed by Schering AG in several European countries and Australia. CoTherix licensed exclusive rights to develop and commercialize iloprost in the U.S. from Schering AG in October 2003 and filed a New Drug Application (NDA) in June 2004. In August 2004, CoTherix's NDA was accepted by the FDA and granted priority review with orphan drug designation.

In previous clinical studies of iloprost monotherapy, common adverse reactions due to iloprost included:

-vasodilation (flushing, 27%),
-cough (39%),
-headache (30%),
-flu syndrome (14%),
-nausea (13%),
-jaw pain (12%),
-hypotension (11%),
-insomnia (8%) and
-syncope (8%);

Other serious adverse events reported with the use of iloprost included congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure. Because of the risk of syncope, vital signs should be monitored while initiating iloprost. Dose adjustments or a change in therapy should be considered if exertional syncope occurs.

Iloprost should not be initiated in patients with systolic blood pressure lower than 85 mm Hg. Stop iloprost immediately if signs of pulmonary edema occur. Iloprost has not been evaluated in patients with chronic obstructive pulmonary disease (COPD), severe asthma, or with acute pulmonary infections.

PAH affects an estimated 50,000 patients in the United States, with only about 15,000 diagnosed and under treatment. Its cause may be unknown, or result from other diseases that cause a restriction of blood flow to the lungs, including scleroderma, HIV and lupus.

Symptoms of the disease include fatigue, shortness of breath on exertion, chest pain and dizziness. Left untreated, the median survival time following diagnosis may be as short as three years.

All rights reserved by www.rxpgnews.com