Profounda announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for Impavido (miltefosine) to treat primary amebic meningoencephalitis (PAM), also known as the “Brain Eating Amoeba”.
Earlier this year, Impavido was used to successfully treat a patient in the Orlando area with a Naegleria fowleri infection. Impavido, an alkylphosphocholine compound, works by acting on key enzymes involved in phospholipid and sterol biosynthesis. As a result of excellent passage though the blood-brain barrier, miltefosine is able to achieve high concentrations of the active drug in the brain tissue.
Impavido is already approved for the treatment of visceral, cutaneous, and mucosal leishmaniasis due to susceptible Leishmania species. It showed in vitro activity against the promastigote and amastigote stages of the Leishmania stages.
Impavido is available as 50mg hard gel capsules in 2×14 blister cards.