Acthar Gel self-injection option available in US, Mallinckrodt says
Pre-filled device available in two dosages, aimed at simplifying treatment
People with multiple sclerosis (MS) and other conditions who use Mallinckrodt‘s treatment Acthar Gel (repository corticotropin injection) now have a self-injection option, the company said.
Acthar Gel Single-Dose Pre-filled SelfJect is available in two dosages — 40 USP units/0.5 ml and 80 USP units/1.0 mL — that patients can give themselves subcutaneously (under the skin) by pressing a handle. The treatment had been available only in a multi-dose, vial-and-syringe package that required patients or their caregivers to draw precise amounts of the medication before administering it.
“The launch of SelfJect is a significant advancement for patients who take Acthar Gel as it is designed to simplify the injection process, help ensure accurate dosing, and has enhanced safety features,” Kostas Botsoglou, MD, managing partner of the Rheumatology Center of Western New York, said in a Mallinckrodt press release. “SelfJect supports patients by helping to make treatment easier to administer than a multi-dose vial and syringe, particularly for patients with dexterity issues.”
Acthar Gel contains a mixture of molecules similar to the adrenocorticotropic hormone (ACTH) and other small proteins that are made by the brain’s pituitary gland. The ACTH hormone can stimulate the production of cortisol, a natural anti-inflammatory molecule, which makes it suitable for a range of inflammatory and autoimmune conditions.
In MS, Acthar Gel is approved to treat acute relapses, or periods of worsening symptoms, to help patients recover faster and more effectively. It is usually considered as an alternative for patients who fail to respond adequately or cannot tolerate corticosteroids — medications that mimic the immune-suppressing action of cortisol and are also used to help control MS relapses. While the treatment does not alter the long-term course of the disease, it provides a tool for managing acute symptoms of MS.
Saving time, minimizing risk
“I’m looking forward to being able to provide this option to appropriate patients in my practice to help them adhere to their treatment plans, which are intended to better their chances for improved outcomes,” Botsoglou said.
The recommended Acthar Gel dosage for MS relapse treatment is 80–120 units, given daily for two to three weeks. The pre-filled, color-coded devices will reduce preparation time and minimize the risk of accidental punctures with needles, Mallinckrodt said.
The multi-dose vial version, administered as a subcutaneous or intramuscular (into-the-muscle) injection, may involve several steps and require extra medical supplies such as needles and syringes, in addition to training for patients and caregivers. The older version will continue to be available for people who prefer that administration method or require doses other than 40 or 80 units, the company said.
“We know that managing chronic and acute inflammatory and autoimmune conditions can be difficult, and we’re proud to offer this new delivery device, designed to better support patients, caregivers, and medical professionals in managing appropriate conditions,” said Lisa French, Mallinckrodt executive vice president and chief commercial officer.
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