PR Pharmaceuticals' PulmoLAR Gets Orphan-Drug Status

The FDA has granted orphan-drug designation to PulmoLAR, PR Pharmaceuticals' lead compound for the treatment of pulmonary arterial hypertension (PAH).

Preclinical experiments and in vitro studies have demonstrated that PulmoLAR (2-methoxyestradiol) addresses many of the pathological processes associated with PAH, the firm said. PR Pharmaceuticals plans to file an investigational new drug application and initiate Phase I studies in 2005 to support continued development of the drug.