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Weekly Drug News Round-Up: October 18, 2017

FDA Approves Lyrica CR Tablets for Neuropathic Pain Conditions

Lyrica CR did not receive approval for the management of fibromyalgia Read More...

The U.S. Food and Drug Administration (FDA) has approved Pfizer’s Lyrica CR (pregabalin) extended-release tablets as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and the management of postherpetic neuralgia (PHN). Lyrica is believed to work on damaged nerves, or to calm overactive nerves. Effectiveness and safety was established in studies of 801 patients with PHN. At least a 50% improvement in pain intensity was shown in roughly 73% of patients in the Lyrica CR group compared with 54% in the placebo group. Common side effects included dizziness, drowsiness, headache, fatigue, fluid retention, nausea, blurred vision, dry mouth and weight gain.

Janssen’s Stelara Cleared for Severe Adolescent Psoriasis

About one-third of individuals who develop plaque psoriasis do so before 20 years of age Read More…

In addition to adults, the interleukin antagonist Stelara (ustekinumab) is now FDA-approved to treat plaque psoriasis in adolescents (12 years of age or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. In studies, at least two-thirds of patients receiving Stelara were responders (cleared or minimal psoriasis) at 12 weeks after the first two doses at week 0 and 4. Stelara is also approved to treat adults with psoriatic arthritis or Crohn's disease. Patients who are treated with Stelara receive only four doses a year (every 12 weeks) after the first two starter doses.

Oral Form of Type 2 Diabetes Injection Under Study

Now in Phase 3 studies, the drug is called semaglutide and is being developed by Novo Nordisk Read More...

Research published this week in the Journal of the American Medical Association (JAMA) reports that a member of an injectable class of type 2 diabetes medication -- called glucagon-like peptide-1 or GLP-1 -- might one day be available in a pill form. In 26 week clinical studies, those receiving the highest 40 mg per day dose of oral semaglutide responded similarly in blood sugar control and weight loss to patients who received weekly injectable semaglutide. Patients on the 40-mg oral dose or the 1 mg injection saw an average drop in their HbA1C of 1.9%. More than 70% of those who took the pill saw a weight loss of at least 5%, ranging up to 15 pounds in patients on the highest dose.

Newer Blood Thinners Not Shown to Boost Bleeding Risk: Study

One downside to these drugs is that they are often more expensive than warfarin with higher co-pays Read More...

Many patients are now using the newer oral anti-clotting drugs like Xarelto (rivaroxaban), Pradaxa (dabigatran) and Eliquis (apixaban). They’re easier to use than the older drug warfarin because they don’t require regular blood testing. An observational study published this week in BMJ suggests the newer agents also don’t have an increased risk of bleeding when compared to warfarin. Researchers found that in 60,000 patients diagnosed with venous thromboembolism (VTE) and prescribed either warfarin or one of the newer direct-acting oral anticoagulants, participants had a similar risk of major bleeding (3%) or death (2%). These results remained constant over a 6 month follow-up period.

Women Often Skip Birth Defect Prevention Before Conception: Poll

About 3,000 babies are born with neural tube defects annually in the U.S. Read More...

Folic acid, a B vitamin, is given to women before and during pregnancy to help prevent neural tube defects in their babies. However, a new poll sponsored by the March of Dimes shows that only one-third of women are taking a multivitamin containing folic acid before conception. Since half of all pregnancies are unexpected, women need to do all they can to be healthy before pregnancy occurs. Up to 70 percent of the neural tube defects, which affect the brain and spine, could be prevented if all women of childbearing age took daily multivitamins containing folic acid. However, 97 percent of women reported taking prenatal vitamins or multivitamins during their pregnancy.