FDA Rejects Asserito's Long-Acting Cosyntropin


Shares of Illinois-based Assertio Therapeutics plunged more than 28% Monday after the company announced the U.S. Food and Drug Administration (FDA) rejected an injectable formulation of long-acting cosyntropin.

Assertio, which was formerly known as Depomed, and its development partner West Therapeutic Development received a Complete Response Letter from the regulatory agency over the synthetic adrenocorticotropic hormone, or ACTH. The companies are seeking approval of the injectable for use as a diagnostic drug in the screening of patients presumed to have adrenocortical insufficiency. The New Drug Application for cosyntropin was accepted by the FDA in February of this year and given a PDUFA date of Oct. 19.

In its brief announcement, Assertio said the FDA informed the companies that “certain pharmacodynamic parameters” were not adequately achieved and that was the primary reason for the rejection. Arthur Higgins, president and chief executive officer of Assertio, said the company, along with West, will work together to “determine how best to address the CRL.” In the meantime, Higgins said the company will continue to focus on generating a strong cash flow for the company.

Long-acting cosyntropin is an alcohol-free formulation of a synthetic analog of ACTH, a hormone secreted from the pituitary gland that is responsible for the stimulation of the adrenal cortex. Cosyntropin is composed of the first 24 of 39 amino acids of natural ACTH and retains the full steroidogenic activity of natural ACTH, the company said.

Adrenal insufficiency occurs when the adrenal glands don’t produce enough hormones, including cortisol. The insufficiency is linked to Addison’s disease. The most common symptoms of the insufficiency are fatigue, muscle weakness, loss of appetite, weight loss, and abdominal pain, according to the Mayo Clinic.

For Assertio, the rejection from the FDA comes weeks after the small company tapped AstraZeneca veteran David Wheadon for its board of directors. Wheadon recently retired from the U.K. pharma giant after serving as head of global regulatory affairs, patient safety and quality assurance.

In addition to cosyntropin, Assertio also has another drug under regulatory review, diclofenac potassium for treatment of mild to moderate acute pain in juvenile patients ages 12 to 17 years. The company also has a migraine treatment in Phase I/II development. The drug is aimed at acute migraine attacks, according to information on the company website.

After the CROL was announced, shares of Assertio fell from $1.17 to 81 cents per share. This morning, the stock saw a slight gain in premarket trading to 84 cents per share.

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