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Low doses of an investigational, delayed-release version of prednisone relieved rheumatoid arthritis symptoms in a pivotal phase III trial, paving the way for a U.S. marketing application, the product's manufacturer said. The oral drug, tradenamed Lodotra, is formulated to begin rapid release of prednisone about four hours after swallowing. Its manufacturer, Swiss-based Nitec Pharma, said that when the drug is taken at bedtime, the release coincides with nocturnal spikes in proinflammatory cytokines, maximizing the steroid's effectiveness. The newly completed U.S. study compared 5 mg of Lodotra once nightly with placebo in a randomized trial involving 350 rheumatoid arthritis patients with inadequate responses to disease-modifying drugs. Conventional prednisone is commonly given in doses of 10 to 20 mg. Some 49% of the Lodotra group achieved ACR 20 responses (20% reduction in symptoms according to American College of Rheumatology criteria), compared with 29% of those taking placebo, the company announced in a press release. The drug also led to a mean 44% reduction in morning stiffness, compared with 21% in the placebo group. Both differences were highly significant (P<0.001), according to Nitec. An earlier European trial tested Lodotra against regular prednisone at an average dose of 6 mg. The delayed-release formulation significantly shortened the duration of morning stiffness and led to greater reductions in interleukin-6 levels, Nitec said. ACR 20 responses and other standard measures of symptom reduction were similar. On the basis of these studies, Nitec said it plans to request FDA approval of the drug for treating rheumatoid arthritis. It was approved in Germany earlier this year. Nitec is also sponsoring a phase II study of the drug in severe asthma and is planning a trial in polymyalgia rheumatica. |