FDA rebuffs little Assertio Therapeutics' long-acting ACTH formulation, shares sink
Tiny Assertio Therapeutics’ shares plunged pre-market on Tuesday, after the FDA has spurned its man-made version of the hormone ACTH, which was being reviewed as a diagnostic for patients presumed to have adrenocortical insufficiency.
The Lake Forest, Illinois-based drugmaker said its development partner West Therapeutic Development had received a complete response letter from the US regulator, which indicated that that certain “pharmacodynamic parameters were not adequately achieved” for the product.
Assertio’s shares $ASRT were down more than 28% at 84 cents pre-market on Tuesday.
The product is an injectable formulation of long-acting cosyntropin (synthetic adrenocorticotropic hormone, or ACTH). The ACTH stimulation test is the most specific test for diagnosing adrenal insufficiency. Blood cortisol levels are measured before and after a synthetic form of ACTH is given by injection. The normal response after the injection is a rise in blood cortisol levels. Patients with adrenal insufficiency see little or no increase in cortisol levels.
Adrenal insufficiency, including Addison’s disease, is a disorder that occurs when the adrenal glands don’t produce adequate levels of certain hormones, including cortisol.
Assertio, which recently wooed former AstraZeneca executive David Wheadon to its board, also has a painkiller under FDA review and an acute migraine therapy in development.
The company does not develop new chemical entities, but rather its technology is designed to allow oral drugs to be retained in the stomach for a period that eclipses the immediate-release and some extended-release formulations that currently exist — thereby theoretically allowing for greater efficacy, increased tolerability, and the convenience of once- or twice-daily dosing. It has three FDA approved products for neurological conditions.