EGRX - Eagle Enalare's ENA-001 for sleep disorder in newborns get FDA orphan drug status

The U.S. Food and Drug Administration (FDA) granted orphan drug designation to Eagle Pharmaceuticals ( NASDAQ: EGRX ) and Enalare Therapeutics' ENA-001 to treat Apnea of Prematurity (AoP).

AoP occurs when newborns, especially those born prematurely, stop breathing for short periods of time (about 20 seconds or more) during sleep.

The disorder is attributed to immaturity of the pulmonary system and ENA-001 is a new chemical entity with a novel mechanism of action as a respiratory stimulant, the company said in an Oct. 3 press release.

"This is an important milestone that builds on the Rare Pediatric Designation granted by the FDA for ENA-001 last December. Currently, pharmacologic treatment for these neonates is typically limited to caffeine or other methylxanthines," said Enalare President and CEO Herm Cukier.

The FDA grants orphan drug status to therapies which treat or prevent rare diseases that affect fewer than 200K people in the U.S. The designation provides certain incentives, including up to seven years of market exclusivity, if approved.

Eagle added that the compound is also being developed for post-operative respiratory depression and community drug overdose.

In September the companies received a contract worth up to $50.3M from a U.S. agency to develop an intramuscular formulation of ENA-001 for patients experiencing community drug overdose.

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