Drug Updates: Citalopram hydrobromide, Statins, and More

Peppermint-flavored escitalopram oxalate oral solution (5 mg/5 mL) is the first generic form of this liquid product to be FDA approved.⁶ Additionally, Teva has been awarded 180-day exclusivity for marketing of generic escitalopram tablets.⁷ Both dosage forms are now available.

Ibandronate 150-mg tablets, the once-monthly tablet to prevent or treat osteoporosis in postmenopausal women, is now available as a generic.⁸ At least three companies received FDA approval of their generic products, therefore the price of this agent will most likely decrease significantly. This generic of Boniva will be available with a medication guide that explains serious reactions associated with its use, including esophageal problems such as inflammation, irritation, or ulcers; hypocalcemia; bone, joint, or muscle pain; osteonecrosis of the jaw; and atypical femur fractures.

LidoPatch (3.99% lidocaine and 1% menthol), an over-the-counter pain patch, was recently FDA approved.⁹

Pipeline

CCX354 is a selective and potent CCR1 antagonist, a chemokine receptor that drives recruitment of inflammatory cells, including monocytes, macrophages, and T cells, into the joints of rheumatoid arthritis (RA) patients.¹⁰ By selectively blocking the CCR1 receptor, CCX354 reduces inflammatory cell infiltration into RA patients’ joints, reducing inflammation, swelling, pain, and joint destruction. Recently, positive outcomes were reported from a phase II clinical trial that investigated the safety, tolerability, and clinical and biological activity CCX354 in patients with RA.

GLPG0634, a selective inhibitor of Janus kinase 1 (JAK1), achieved its primary endpoint of significant improvement in the signs and symptoms of RA, with 83% of patients showing improvement in ACR20 score at four weeks.¹¹ Additionally, half of the treated patients went into remission or showed a low-disease activity at Week Four. No anemia or increases in cholesterol or low-density lipoproteins were seen. No severe adverse events were reported in patients that received the agent.

Ixekizumab and brodalumab are two investigational interleukin (IL)-17 inhibitors being studied in patients with psoriasis.¹² In phase II clinical trials, there seemed to be a lack of significant side effects, which is a plus for many of these biologic agents. However, because they suppress the immune system, there is always the potential for an increased infection risk. If these agents continue to do well in clinical trials, patients may soon have biologic options in additional to tumor necrosis factor–α inhibitors.

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. FDA Drug Safety Communication: Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high doses. Published March 28, 2012. Available at www.fda.gov/Drugs/DrugSafety/ucm297391.htm. Accessed March 29, 2012.
2. FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs. Published February 28, 2012. Available at www.fda.gov/Drugs/DrugSafety/ucm293101.htm#data. Accessed March 27, 2012.
3. Mercury poisoning linked to skin products. Published March 6, 2012. Available at www.fda.gov/ForConsumers/ConsumerUpdates/ucm294849.htm?source=govdelivery. Accessed March 27, 2012.
4. Brooks M. 2012 EMA recommends new warnings on bone drug. Published March 16, 2012. Available at www.medscape.com/viewarticle/760408. Accessed March 16, 2012.
5. FDA approves BINOSTO, first and only effervescent osteoporosis treatment in a buffered solution. Published March 14, 2012. Available at www.effrx.com/news/20120314. Accessed March 27, 2012.
6. Cerra A. Amneal launches liquid generic Lexapro. Published March 15, 2012. Available at http://drugstorenews.com/article/amneal-launches-liquid-generic-lexapro. Accessed March 27, 2012.
7. Cerra A. Teva launches generic Lexapro, awarded 180-day exclusivity. Published March 22, 2012. Available at http://drugstorenews.com/article/teva-launches-generic-lexapro-awarded-180-day-exclusivity. Accessed March 27, 2012.
8. Dane L. FDA approves first generic versions of Roche’s Boniva. Published March 19, 2012. Available at www.firstwordpharma.com/node/961550. Accessed March 27, 2012.
9. Johnsen M. JAR Labs launches OTC lidocaine pain patch. Published February 9, 2012. Available at http://drugstorenews.com/article/jar-labs-launches-otc-lidocaine-pain-patch. Accessed February 12, 2012.
10. GSK exercises option to license ChemoCentryx’s CCR1 Inhibitor, CCX354, for the treatment of rheumatoid arthritis. Published January 5, 2012. Available at http://ir.chemocentryx.com/releasedetail.
11. Galapagos’ GLPG0634 shows excellent efficacy and safety in rheumatoid arthritis Phase II study. Published November 22, 2011. Available at www.glpg.com/index.php/randd/pipeline/glpg0634-ra. Accessed March 27, 2012.
12. Storrs C. Two experimental drugs could improve psoriasis treatment. Published March 29, 2012. Available at http://consumer.healthday.com/printer.asp?AID=663196. Accessed March 29, 2012.