adidas originals superstar 80s First Patient Enrolled in Mallinckrodt Phase 4 Trial of H
Information contained on this page is provided by an independent third party content provider. Frankly and this Site make no warranties or representations in connection therewith. Acthar Gel as a therapy option in patients with pulmonary sarcoidosis. Food and Drug Administration (FDA) for the respiratory condition symptomatic sarcoidosis, one of 19 indications.”I am pleased that the first patient has been enrolled in this important Phase 4 study, the results of which may potentially provide evidence to further support Acthar as a treatment option in appropriate symptomatic sarcoidosis patients,” said Dr. Acthar Gel in the treatment of pulmonary sarcoidosis. Acthar Gel or 1mL of a matching placebo subcutaneously 2 times/week. Subjects will be assigned to treatment in a 1:1 ratio with up to 50 subjects per arm for a total of up to 100 subjects. Subjects who complete the 24 week randomized, double blind, placebo controlled treatment period will be eligible to continue in an optional 24 week open label extension.Response will be evaluated by Sarcoidosis Treatment Score (STS) with a time frame of baseline to 24 weeks. STS is an exploratory newly developed composite score that combines the results of pulmonary function tests (forced vital capacity; diffusing capacity of the lungs for carbon monoxide), high resolution computed tomography, quality of life (King Sarcoidosis Questionnaire; Fatigue Assessment Scale) and corticosteroid tapering. In some cases the symptoms may come and go throughout a lifetime. This is referred to as symptomatic sarcoidosis. In people with sarcoidosis the immune system overreacts, forming clumps of cells called granulomas that result in inflammation to the body tissues. The disease can impact any organ, but it most often impacts the lungs, lymph nodes, eyes, and skin. Over 90 percent of people with sarcoidosis will suffer lung problems. Concomitant involvement of organs outside of the lungs is common, occurring in as many as half of all sarcoidosis cases. Acthar Gel is an injectable drug approved by the FDA for the treatment of 19 indications. Of these, today the majority of Acthar use is in these indications:Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosusMonotherapy for the treatment of infantile spasms in infants and children under 2 years of ageThe treatment of acute exacerbations of multiple sclerosis in adults. Acthar Gel to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the diseaseInducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosusTreatment during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis)The treatment of symptomatic sarcoidosisAdjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy)Treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammationIMPORTANT SAFETY INFORMATIONThe adverse effects of Acthar are related primarily to its steroidogenic effectsActhar may increase susceptibility to new infection or reactivation of latent infectionsSuppression of the hypothalamic pituitary axis (HPA) may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA suppression after stopping treatmentCushing syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptomsActhar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Blood pressure, sodium and potassium levels may need to be monitoredActhar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapyActhar can cause GI bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain gastrointestinal disorders. Monitor for signs of bleedingActhar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression, and psychosis. Existing conditions may be aggravatedPatients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravisProlonged use of Acthar may produce cataracts, glaucoma and secondary ocular infections. Monitor for signs and symptomsActhar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH activityThere is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liverLong term use may have negative effects on growth and physical development in children. Monitor pediatric patientsDecrease in bone density may occur. Bone density should be monitored for patients on long term therapyPregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetusAdverse ReactionsCommon adverse reactions for Acthar are similar to those of corticosteroids and include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gainSpecific adverse reactions reported in IS clinical trials in infants and children under 2 years of age included: infection, hypertension, irritability, Cushingoid symptoms, constipation, diarrhea, vomiting, pyrexia, weight gain, increased appetite, decreased appetite, nasal congestion, acne, rash, and cardiac hypertrophy.Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. 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