Drug Updates: Information on New Approvals and Medication Safety

A number of oral forms of calcitonin are currently in the pharmaceutical pipeline. Bone Medical Limited is currently investigating Capsitonin in phase II clinical trials for the treatment of osteoporosis.²² Tarsa Therapeutics has an investigational oral calcitonin product currently in phase III clinical trials to treat osteoporosis.²³ Finally, Novartis is investigating an oral calcitonin product to treat postmenopausal osteoporosis.²⁴

Another new class of agents to manage osteoporosis includes cathepsin K inhibitors. One agent, MK-0822 or odanacatib, is currently in phase III clinical trials.25 This agent selectively inhibits the cathepsin K enzyme, which plays a pivotal role in osteoclast function.26 Time will tell which of these new biologic or nonbiologic agents will make it through clinical trials and be approved to manage osteoporosis.

Michele Kaufman is a freelance medical writer based in New York City.

References

1. FDA approves Pennsaid Topical Solution. www.drugs.com/newdrugs/fda-approves-pennsaid-topical-solution-1758.html 2. Published November 5, 2009; Accessed December 2, 2009.
2. Update-1 Nuvo shares surge on FDA pain cream approval. www.reuters.com/article/email/idUSN0543459820091105. Published November 5, 2009. Accessed December 2, 2009.
3. Prevacid 24HR hr available over-the-counter. www.empr.com/prevacid-24hr-available-over-the-counter/article/157592. Published November 12, 2009. Accessed December 2, 2009.
4. Teva receives final approval for generic Prevacid delayed-release capsules. www.tevapharm.com/pr/2009/pr_882.asp. Published November 10, 2009. Accessed December 2, 2009.
5. Zegerid OTC approved for frequent heartburn. www.empr.com/zegerid-otc-approved-for-frequent-heartburn/article/158881. Published December 2, 2009. Accessed December 2, 2009.
6. Javelin Pharmaceuticals submits Dyloject New Drug Application to FDA for management of Acute Moderate-to-Severe Pain in Adults. http://ir.javelinpharmaceuticals.com/releasedetail.cfm?ReleaseID=427752. Published December 2, 2009. Accessed December 2, 2009.
7. Feedback on Exalgo NDA. www.drugs.com/nda/exalgo_091116.html. Published November 16, 2009. Accessed December 2, 2009.
8. POZEN announces start of enrollment for PA32540 Phase 3 program. http://phx.corporate-ir.net/phoenix.zhtml?c=121701&p=irol-NRText&ID=1357809&highlight=. Published November 20, 2009. Accessed December 2, 2009.
9. FDA nixes wider use of rheumatoid arthritis drug-FDA rejects expanded use of rheumatoid arthritis drug Rituxan. www.cbsnews.com/stories/2009/10/17/ap/business/main5392451.shtml. Published October 17, 2009. Accessed December 2, 2009.
10. Actemra improves signs and symptoms in children with systemic onset juvenile idiopathic arthritis. www.roche.com/investors/ir_update/inv-update-2009-11-20.htm. Published November 20, 2009. Accessed December 2, 2009.
11. Pharmaceutical Research and Manufacturer’s Association 2008 Report-Medicines in Development: Biotechnology. www.phrma.org/medicines_in_development_for_biotechnology. Published November 3, 2008. Accessed December 2, 2009.
12. Amgen provides update on status of Prolia (Denosumab) biologics license application (BLA) submitted to the U.S. Food and Drug Administration (FDA). wwwext.amgen.com/media/media_pr_detail.jsp?year=2009&releaseID=1343288. Published October 19, 2009. Accessed December 2, 2009.
13. Lewiecki EW. Current and emerging pharmacologic therapies for the management of postmenopausal osteoporosis. J Women’s Health. 2009;18:1615-1626.
14. Lewiecki EW. Denosumab update. Curr Opin Rheumatology. 2009;21:369-373.
15. Cummings SR, San Martin J, McClung MR, et al for the FREEDOM Trial investigators. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009;361:756-765.
16. Lacey DL, Timms E, Tan HL, et al. Osteoprotegerin ligand is a cytokine that regulates osteoclast differentiation and activation. Cell. 1998;93:165-176.
17. Smith MR, Egerdie B, Hernández Toriz N, et al. Denosumab in men receiving androgen-deprivation therapy for prostate cancer. N Engl J Med. 2009;361:745-755.
18. McClung MR, Lewiecki EM, Cohen SB, et al. Denosumab in postmenopausal women with low bone mineral density. N Engl J Med. 2006;354:821-831.
19. Khosla S. Increasing options for the treatment of osteoporosis. N Engl J Med. 2009;361:818-820.
20. Wyeth Pharmaceuticals Development Pipeline. www.pfizer.com/files/research/pipeline/2009_0506/pipeline_2009_0506.pdf. Published May 6, 2009. Accessed December 2, 2009.
21. A study for the transdermal application of teriparatide. http://clinicaltrials.gov/ct2/show/NCT01011556?term=forteo+transdermal&rank=1. Published November 16, 2009. Accessed December 2, 2009.
22. Bone Medical Ltd website. www.bone-ltd.com/bn002.htm Accessed December 2, 2009.
23. Tarsa Therapeutics receives license for Phase III oral calcitonin program. www.news-medical.net/news/20091020/Tarsa-Therapeutics-receives-license-for-Phase-III-oral-calcitonin-program.aspx. Published October 20, 2009. Accessed December 2, 2009.
24. A study to evaluate oral salmon calcitonin in the treatment of osteoporosis in postmenopausal women taking calcium and vitamin D. http://clinicaltrials.gov/ct2/show/NCT00525798?term=SMC021&rank=3. Published November 13, 2008. Accessed December 2, 2009.
25. Merck October combined pipeline. www.merck.com/research/pipeline/Merck%20October%202009%20Combined%20Pipeline.pdf. Published October 15, 2009. Accessed December 2, 2009.
26. New, long-term data for odanacatib, Merck’s investigational cat K inhibitor, showed positive results in treating osteoporosis. www.merck.com/newsroom/news-release-archive/research-and-development/2009_0914.html. Published September 14, 2009. Accessed December 2, 2009.