New Products for Pharmacists

Rx Care

New drugs

FDA has approved Celgene’s apremilast (Otezla) 30 mg to treat adults with active psoriatic arthritis (PsA), a condition characterized by joint pain, stiffness, swelling, and impaired physical function. The product, an inhibitor of phosphodiesterase-4 (PDE-4), is the first oral therapy formulated for this condition. It is dosed twice daily. In clinical trials, the most common side effects observed in patients were diarrhea, nausea, and headache. FDA is requiring a pregnancy exposure registry as a post-marketing requirement to assess the risks to pregnant women related to apremilast exposure. (www.otezla.com)

FDA has approved Mallinckrodt’s oxycodone hydrochloride/acetaminophen 7.5 mg/325 mg extended-release tablets (CII) (Xartemis XR), dosed two tablets every 12 hours, for the management of acute pain requiring opioid treatment. This product is also indicated for patients unresponsive to other treatments. It is the first and only extended-release oral combination of two pain medications, delivering both immediate and extended relief. The product begins to affect symptoms in less than 60 minutes. Serious adverse events may include respiratory depression and hepatotoxicity. Common adverse events include nausea, dizziness, headache, vomiting, constipation, and somnolence. Approval included a boxed warning for addiction, abuse, and misuse; life-threatening respiratory depression; accidental exposure; neonatal opioid withdrawal syndrome; and hepatotoxicity. (www.mallinckrodt.com)

AstraZeneca announced FDA approval of exenatide extended-release for injectable suspension 2 mg (Bydureon pen), for once-weekly use by adults with type 2 diabetes as an addition to diet and exercise, to improve glycemic control. The prefilled, single-use pen injector contains the same formula and dose as the original Bydureon single-dose tray. AstraZeneca said it plans to make the pen available for patients later this year. The single-dose tray will remain available. (http://www.bydureon.com)

Teva has launched loxapine inhalation powder, 10 mg (Adasuve), the first orally inhaled drug for the acute treatment of agitation associated with schizophrenia or bipolar 1 disorder in adults. Administration is performed with Staccato, a single-use, hand-held device from Alexza Pharmaceuticals. The device provides rapid systemic drug delivery as the patient inhales a thermally-generated aerosol of loxapine, a first generation antipsychotic. Absorption is rapid, with a maximum plasma concentration achieved in approximately two minutes. (www.adasuve.com)

New formulations

Image courtesy of MerckIn March, Merck announced that FDA had approved the intravenous antifungal treatment posaconazole injection (Noxafil) 18 mg/mL. Posaconazole is also available as a 100-mg delayed-release tablet and in 40 mg/mL oral suspension. All three are indicated to treat invasive Aspergillus and Candida infections in high-risk patients who are severely immunocompromised or whose white-blood-cell counts have been lowered by chemotherapy. The IV form is given as a once-daily maintenance dosing following a twice-daily loading dose on the first day of therapy. It can be administered to patients 18 years of age and older. The tablets and oral suspension are indicated for patients 13 years of age and older. See the PI for contraindications. (www.merckconnect.com/noxafil/overview.html)

FDA has approved once-daily topiramate extended-release capsules (Qudexy XR, Upsher-Smith Laboratories) in 25-mg, 50-mg, 100-mg, 150-mg, and 200-mg formulations for initial antiepileptic monotherapy in patients 10 years of age and older with partial-onset seizures (POS) or primary generalized tonic-clonic seizures. It is also approved as adjunctive therapy in patients two years of age and older who have POS, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome. Qudexy XR will be available to patients in the second quarter of 2014. Clinical trial results showed the product effective as adjunctive therapy in patients with refractory POS. Patients who have metabolic acidosis and also take metformin should not take this product. (www.qudexyxr.com)

New indications

Image courtesy of Bristol-Myers Squibb/Pfizer

Bristol-Myers Squibb and Pfizer announced that FDA has approved a new indication for apixaban (Eliquis) to reduce the risk of blood clots after surgery to replace knees or hips. Apixaban is also approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The new treatment option is dosed twice daily, and routine coagulation is not required. A boxed warning notes increased stroke risk for patients with nonvalvular atrial fibrillation who discontinue use without adequate continuous anticoagulation, as well as increased risk of epidural or spinal hematoma. Three clinical trials enrolling more than 11,000 patients assessed the safety and efficacy of the product. (www.eliquis.com)

Image courtesy of Genentech/NovartisFDA has approved a supplemental indication for omalizumab (Xolair; Genentech/Novartis) for chronic idiopathic urticaria (CIU), a form of chronic hives that can cause severe itch and swelling that can last for many months and even years. It is indicated for use by patients 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy. Omalizumab is not used to treat other forms of urticaria (hives) and is not for use in children less than 12 years of age. It is administered by subcutaneous injection. Omalizumab is the first biologic treatment and first medication approved by FDA for CIU since H1-antihistamines. Nearly 50% of patients remain symptomatic despite treatment with approved doses of H₁-antihistamines. (www.xolair.com.)

FDA has approved the pediatric drug propranolol hydrochloride (Hemangeol, Pierre Fabre Pharmaceuticals), the first and only treatment approved for proliferating infantile hemangioma requiring systemic therapy. While propranolol is a long-established agent in cardiology treatment, no pharmaceutical form was approved for pediatric use before clinical trials were launched in 2009. When the product was studied in infants five weeks to five months old, the oral solution, dosed at 3 mg/kg/day for six months, showed a 60.4% success rate vs. 3.6% in the placebo group and reached the study’s primary endpoint: complete or nearly complete resolution of the target hemangioma. Adverse reactions included sleep disorders, aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever, diarrhea, and vomiting. The product will be available in June. (www.hemangeol.com)

New generics

Teva has announced the U.S. launch of its new capecitabine tablets, 150 mg and 500 mg, the generic equivalent to Genentech’s Xeloda tablets. Teva was the first to receive FDA approval of its ANDA for the product and the concomitant 180-day marketing advantage. Capecitabine is used to treat cancers of the colon, breast, or rectum that have metastasized. (www.tevagenerics.com)

Teva was also the first company to file for raloxifene tablets, 60 mg (generic for Evista; Eli Lilly), in the United States, gaining 180 days of marketing exclusivity, and expects to start shipping the product this month. Raloxifene is used to prevent and treat osteoporosis in postmenopausal women. (www.tevagenerics.com)

Dr. Reddy’s Laboratories has launched moxifloxacin HCl tablets, 400 mg, a therapeutic equivalent generic version of Avelox (Bayer Pharma AG). Moxfloxacin is a fluoroquinolone indicated for the treatment of adults with community-acquired pneumonia, acute exacerbations of chronic bronchitis, acute bacterial sinusitis, complicated skin and skin structure infections, pelvic inflammatory disease, and complicated intra-abdominal infections. (www.drreddys.com)

Perrigo has launched methazolamide 25 mg tablets, a glaucoma treatment that is the generic version of Neptazane tablets, made by Fera Pharmaceuticals. The product lowers intraocular pressure and treats conditions such as chronic open-angle glaucoma and secondary glaucoma. It is also used preoperatively in acute angle-closure glaucoma. (www.perrigo.com)

FDA has approved Lupin’s doxycycline capsules USP, 50 mg, 75 mg, and 100 mg (generic for Monodox capsules; Aqua Pharmaceuticals). The drug is used to treat infections caused by various microorganisms and as an adjunctive therapy in severe acne. (www.lupinpharmaceuticals.com)

Lupin also received FDA approval for its ciprofloxacin for oral suspension 5 g/100 mL (250 mg/5 mL) and 10 g/100 mL (500-mg/5-mL), (generic for Cipro for oral suspension; Bayer HealthCare Pharmaceuticals), used to treat a wide variety of infections. (www.lupinpharmaceuticals.com)

FDA has also given its approval to Lupin’s rifabutin capsules USP, 150 mg (generic for Mycobutin, Pharmacia/Upjohn Company). The company’s U.S. subsidiary will begin marketing the product soon. The product is used to prevent disseminated Mycobacterium avium complex disease in patients with advanced HIV infection. (www.lupinpharmaceuticals.com)