New Products

Rx CARE

New Rx

Antares Pharma has announced FDA approval of Otrexup, a drug/device version of methotrexate that delivers 0.4 mL of drug by disposable, single-dose, subcutaneous auto-injector in 10-mg, 15-mg, 20-mg, and 25-mg dosage strengths, for treatment of rheumatoid arthritis (RA) and psoriasis. Injected by the patient underneath the skin once a week, the product is intended for adults with severe RA who have shown inadequate response to full-dose nonsteroidal anti-inflammatory drugs, children with polyarticular juvenile idiopathic arthritis, and adults with severe, resistant, disabling psoriasis when other types of treatment have been used and did not work well. Otrexup should not be used for the treatment of children with psoriasis. Common side effects of Otrexup include nausea, stomach pain, indigestion (dyspepsia), mouth sores, and rash. Other side effects include fertility problems, certain cancers, and tissue and bone problems. The product carries a boxed warning about severe reactions, including embryofetal toxicity and organ toxicity that may affect the gastrointestinal system, bone marrow, liver, immune system, nervous system, lungs, kidneys, and skin, and increase the risk of death. Contraindications include pregnancy, nursing mothers, alcoholism or liver disease, immunodeficiency syndromes, preexisting blood dyscrasias, and hypersensitivity to methotrexate. This product can interact with aspirin, NSAIDs, and steroids, and proton pump inhibitors. (www.otrexup.com)

Last month, FDA approved vortioxetine (Brintellix, Takeda/Lundbeck) tablets in 5-mg, 10-mg, and 20-mg strengths to treat adults with major depressive disorder (MDD). Symptoms of MDD include mood changes and disrupted work, sleep, study, meals, and pastimes previously found pleasurable. Vortioxetine was found an effective treatment for depression in six clinical studies. Another study showed that it decreased the likelihood that depression would recur. The most common side effects included nausea, constipation, and vomiting. The product carries a boxed warning and a medication guide alerting patients and healthcare professionals to increased risk of suicidal thoughts and behavior in children, adolescents, and young adults 18 to 24 years of age. Patients beginning antidepressant therapy should be closely monitored for worsening of their depression and the emergence of suicidal thoughts and behavior. (http://www.brintellix.com)

FDA has approved Bayer's riociguat (Adempas) tablets, a new class of drug (sGC, a stimulator of soluable guanylate cyclase), formulated to treat adults with either (i) persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class; or (ii) pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class, and delay clinical worsening. It is the first and only drug approved by FDA for treatment of two forms of pulmonary hypertension. It is also the only approved oral therapy in PAH with efficacy shown in monotherapy or in combination with ERAs or prostanoids. It is available to all female patients only through a REMS program and carries a boxed warning of embryofetal toxicity. Most commonly reported adverse reactions include headache, dyspepsia/gastritis, dizziness, nausea, diarrhea, hypotension, vomiting, anemia, gastroesophageal reflux disease, and constipation. Contraindications include pregnancy, co-administration with nitrates or nitric oxide donors, and concomitant administration with phosphodiesterase (PDE) inhibitors. (www.adempas-us.com)

Pfizer announced in October that FDA had approved its formulation of conjugated estrogens 
0.45 mg/bazedoxifene 20 mg (Duavee), which it is developing with Ligand Pharmaceuticals, to treat women with moderate to severe menopause symptoms and to prevent postmenopausal osteoporosis, which would reduce the risk of fractures. Duavee is the first and only therapy to pair conjugated estrogens with an estrogen agonist/antagonist, also known as a selective estrogen receptor modulator. The company expects this product to reduce hot flashes with fewer side effects than are produced by older hormone-replacement therapies. The product carries a boxed warning for increased risk of endometrial cancer, cardiovascular disorders, and probable dementia. Common adverse reactions in clinical tests included muscle spasms, nausea, diarrhea, dyspepsia, abdominal pain upper, oropharyngeal pain, dizziness, and neck pain. Contraindications include undiagnosed abnormal uterine bleeding; history of breast cancer; estrogen-dependent neoplasia; history of venous or arterial thromboembolism; hypersensitivity (angioedema,anaphylaxis) to estrogens, bazedoxifene, or other ingredients;  hepatic impairment or disease; protein C, protein S, or antithrombin deficiency or other known 
thrombophilic disorders; and potential pregnancy, pregnancy, or breast-feeding. Patients taking Duavee should add supplemental calcium and/or vitamin D to their diets if their daily intake is inadequate. The product is packaged in two blisters of 15 tablets each. The company expects to start shipping the product by February 3, 2014. (http://www.duavee.com)

New generics

Last month Teva announced the U.S. launch of its paricalcitol tablets, the generic equivalent to AbbVie’s Zemplar, in 1-mcg, 2-mcg, and 4-mcg strengths. Because Teva was first to file, the product will have 180 days of marketing exclusivity. Paricalcitol is an active form of vitamin D used to prevent and treat secondary hyperparathyroidism (increased parathyroid hormone levels) in patients with Stage 3 or 4 chronic kidney disease and in Stage 5 patients on dialysis. Vitamin D and paricalcitol have been shown to reduce parathyroid hormone levels by inhibiting parathyroid hormone synthesis and secretion. (www.tevagenerics.com)

Also in October, FDA approved Teva's tobramycin inhalation solution, a generic version of Novartis’ Tobi, an inhaled antibiotic for treating lung infections in patients with cystic fibrosis. Teva expects to launch its generic product by the end of this month. (www.tevagenerics.com)

Mylan has launched its voriconazole for oral suspension in the 40-mg/mL strength, the first generic version of Pfizer’s Vfend for treatment of invasive fungal infections. As the first company to receive approval for a generic version, Mylan has 180 days in which to compete exclusively against Pfizer's product. (http://www.mylan.com)

Also recently approved is Sun Pharmaceutical’s lansoprazole in delayed-release capsules (15 mg and 30 mg), a generic version of Takeda's Prevacid, for treatment of active duodenal ulcers. (http://www.sunpharma.com)

New OTC

The Klean Athlete nutritional supplement line from Douglas Laboratories has launched KLEAN-D, a vitamin D supplement designed to aid in muscle recovery and help support immunity and musculoskeletal strength in athletes. The product is NSF-Certified for Sport, meaning that it has been tested and found to be free of banned substances. It is estimated that 1 billion people are deficient in vitamin D. (These statements have not been evaluated by FDA. These products are not intended to diagnose, treat, cure or prevent any disease.) Other items in this product line include Klean Multivitamin, Klean Antioxidants, Klean Cognitive, Klean Probiotic, Klean Isolate, Klean Electrolytes, and Klean Endurance. (www.kleanathlete.com)

In October, the HealFast Skincare line from Fortitude Health LLC announced the release of Scarblock cream, specifically formulated to prevent scarring after plastic surgery or injuries. It can be applied soon after surgery, while stitches are still in place. The product contains vitamins, minerals, and proteins, including Helichrysum italicum (Everlasting) flower oil, said to help fade scars, heal stretch marks, and reduce the appearance of surgical scars and skin blemishes. According to the manufacturer, the diketones in this essential oil help reduce scar tissue and stimulate the growth of new skin tissue. The product is also intended to soothe, nourish, and hydrate the skin, and promote collagen production. It may diminish the appearance of older scars. It contains no paraben, synthetic fragrances, or artificial colors, and no animal testing was involved in its development. A .5-oz six-week supply retails for $50. (http://www.healfastskincare.com)

An OTC product appropriate to the season is TheraNeem Naturals’ Soothing Therape Chest Rub from Organix-South. This bronchial support cream is formulated with botanically derived adapatogens, antioxidants, and essential oils to soothe discomfort from minor bronchial irritations during the cold-and-flu months. According to the manufacturer, menthol and eucalyptus vapors help to open airways and promote relaxation, while extracts of holy basil, ashwagandha, neem, and tea tree oil protect and warm the skin. The product can be applied to the chest, throat, nose and back. The cruelty-free logo appears on the package. (www.organixsouth.com)

Also suitable for the time of year is Thumbs Up from Amazing Grace Super Naturals, a spray formulated for use on the painful skin splits and cuts that start to appear in winter on the corners of thumbs and fingers. The product’s blend of healing ingredients is derived from nature and includes honey, apple cider vinegar, rosemary essential oil, lemon, and aloe vera. Enough spray should be applied to soak the split skin. According to the manufacturer, there may be a slight stinging sensation; pain relief should follow. Application can be repeated until healing is complete. This product is available at grocery and drug retailers, organic and natural retailers, and outdoor and sporting goods retailers. It also can be ordered from the product website. (http://www.YourThumbsUp.com)