Mallinckrodt Pharmaceuticals

Acthar Gel (repository corticotropin injection) may be useful for managing disease relapses in people with relapsing-remitting multiple sclerosis (RRMS) who fail to respond to treatment with corticosteroids, according to results from a small clinical trial. The study, “Results from a multicenter, randomized, double-blind, placebo-controlled study…

There is minimal evidence that the expensive anti-inflammatory medication Acthar Gel (repository corticotropin injection) is more effective than inexpensive corticosteroids for the treatment of multiple sclerosis (MS) and other diseases, according to a new review paper. “We found no evidence where it was a conclusive slam dunk that…

The injectable ACTH gel medication Cortrophin Gel (repository corticotropin injection), first introduced in the U.S. in the 1950s, will now be relaunched as a treatment for acute flare-ups in multiple sclerosis (MS) and other autoimmune conditions, following its approval by the U.S. Food and Drug Administration (FDA). In…

Editor’s note: “Need to Know” is a series inspired by common forum questions and comments from readers. Have a comment or question about MS? Visit our forum. This week’s question is inspired by the forum post “MS Treatment Eases Flare-up Symptoms After 2 Months” from Oct.

ANI Pharmaceuticals is asking the U.S. Food and Drug Administration (FDA) for the right to reintroduce in the U.S. market its Cortrophin Gel (repository corticotropin injection, 80 U/ml) to treat acute exacerbations in multiple sclerosis (MS) and other diseases. Currently, the only repository corticotropin injection available in…

Acthar Gel (repository corticotropin injection) leads to significant improvements after two months of use in people with multiple sclerosis (MS) still having acute relapses despite treatment, and who failed to respond to other high-dose corticosteroids, topline data from an observational study show. The gel’s developer, Mallinckrodt Pharmaceuticals, also…

Acthar Gel (repository corticotropin injection) is more effective for treating flares in multiple sclerosis (MS) than other alternatives, including intravenous immunoglobulin or plasmapheresis, a claims-based study from Mallinckrodt Pharmaceuticals reports. The study “Treatment Effectiveness for Resolution of Multiple Sclerosis…

Acthar Gel (repository corticotropin injection) eased flare-up symptoms in patients with multiple sclerosis (MS) experiencing relapses, top-line data from an observational registry study shows. Acthar Gel, a medication developed and marketed by Mallinckrodt Pharmaceuticals, is a compound that enhances the production of steroids in the…

Late-line use of H.P. Acthar Gel to treat relapses in adults with multiple sclerosis (MS) is linked with lower costs than other therapies used after an initial poor response, including plasmapheresis and intravenous immunoglobulin, according to an analysis by Mallinckrodt Pharmaceuticals, the treatment’s marketer. George Wan, PhD, Mallinckrodt’s vice president and…

Mallinckrodt Pharmaceuticals is seeking 66 participants for a clinical trial to determine the safety and effectiveness of its injected therapy H.P. Acthar Gel as a treatment for acute relapses in people with relapsing-remitting multiple sclerosis (RRMS). MS relapses are flare-ups of central nervous system inflammation that damage the myelin coating that protects nerve cells. The damage disrupts the transmission of impulses between the cells, causing spikes in MS symptoms. For severe relapses that interfere with a person’s mobility, safety or ability to function, most neurologists recommend corticosteroid treatment administered intravenously or taken orally. Steroids can also be administered by injection of a gel under the skin. H.P. Acthar Gel is designed to provide extended release of steroids in the body. The trial will evaluate whether the gel is an effective treatment for RRMS patients who have been unable to recover from a relapse after receiving high-dose intravenous or oral steroids. Researchers will randomly assign participants to receive either H.P. Acthar Gel or a placebo, delivered by injection once a day for 14 days. Follow-up visits will be required at 14, 28 and 42 days. The study's main objective will be seeing whether patients' disability improves. Researchers will use a standard tool for measuring disability known as the Expanded Disability Status Scale.  Other objectives will include seeing how the therapy affects patients' fatigue, quality of life, workplace productivity, and use of healthcare resources. Participants must have a confirmed diagnosis of RRMS, be older than 18 years of age, and have experienced a relapse within 29 days of enrolling in the trial. For more information about enrollment criteria and how to participate in the trial, please contact Valerie Carvajal at (800) 556-3314 or by email at [email protected]. The National Multiple Sclerosis Society announced in an MS trial alert that Mallinckrodt will be  enrolling participants in Tucson; Fort Collins, Colo.; Tampa; Atlanta; Savannah, Ga.; Northbrook, Ill.; Fort Wayne, Ind.; Indianapolis; Kansas City, Kan.; New York; Cleveland; Dayton, Ohio; Dallas; Round Rock, Texas; San Antonio; Salt Lake City; Richmond, Va.; and Tacoma, Wash. Without clinical trial participation there is no way for patients to obtain new medicines or for scientists to ultimately find a cure for MS. The National MS Society encourages participation. It has developed a guide for patients who want to take part in studies called “Participating in Clinical Trials.” It covers the basics of participation, benefits versus risks, patient protection, costs and other important issues about trials.  

Medicare spent more $650 million in 2013 and 2014 on one single medication — H.P. Acthar Gel —— that was prescribed by fewer than 1 percent of clinicians to treat multiple sclerosis (MS), with questionable results. That’s the conclusion of new research by Oregon Health and Science University (OSHU), which presented its…

A recent study analyzing the healthcare resource use and cost of H.P. Acthar Gel, an injectable drug used to manage multiple sclerosis (MS) relapse, demonstrated that the therapy is a viable alternative to plasmapheresis (PMP) and intravenous immunoglobin (IVIG). Annual direct healthcare costs encountered by MS patients in the U.S.

Clinical results presented at the recent Academy of Managed Care Pharmacy (AMCP)‘s 2016 annual meeting in San Francisco showed that the use of H.P. Acthar Gel during multiple sclerosis (MS) relapses is associated with beneficial outcomes. The gel, according to its producer, is also available at a lower price than other frequently used…

The non-profit organization MS News and Views (MSVN) announced that it will host four educational events during the month of August for both patients and other people interested in learning more about multiple sclerosis (MS). The educational events reflect the organization’s ongoing mission, which is to collect, present and…