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Orphan Drug Development During the past year the Foundation has become aware of the existence of a number of drug compounds that hold significant promise for managing PPH but which are not being made available to patients. These compounds are not in clinical trials for PPH because the size of the PPH community is too small to financially justify, for some large pharmaceutical companies, the multi-million dollar costs associated with clinical trials and regulatory approval. Some of the compounds are long-acting oral forms (Schering's Iloprost and Toray's Beraprost) of the prostacyclin approved by the FDA for continuous intravenous use (Glaxo's Flolan). There are also other existing drug compounds that may arrest PPH by blocking certain endothelin receptors, by modulating the potassium ion channel in the vascular smooth muscle, and by inhibiting the formation of obliterative plexiform lesions in the pulmonary arterioles. These compounds are being developed for non-PPH conditions because those conditions affect much larger patient populations and thus offer greater promise of an acceptable financial plan. |
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