Hydrocodone rescheduling amendment and pipeline products on the horizon

P and T

Volumn 37, Issue 7, 2012, Pages 399-404

  Gershman, Jennifer A ^a   Fass, Andrea D ^b  

^a NOVA SOUTHEASTERN UNIVERSITY   (United States)

^b LONG ISLAND UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HYDROCODONE; HYDROCODONE BITARTRATE; UNCLASSIFIED DRUG; ZOHYDRO;

DRUG CLASSIFICATION; DRUG FORMULATION; DRUG MANUFACTURE; DRUG RELEASE; EDITORIAL; FOOD AND DRUG ADMINISTRATION; MEDICAL SOCIETY;

EID: 84865956066     PISSN: 10521372     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Editorial

References (16)

1. Drug Enforcement Administration. Hydrocodone, June 2011. Available at: www.deadiversion.usdoj.gov/drugs_concern/hydrocodone.pdf. Accessed June 11, 2012.
2. U.S. Department of Health and Human Services. Results from the 2010 National Survey on Drug Use and Health: Summary and National Findings, September 2011. Available at: www.samhsa.gov/data/NSDUH/2k10NSDUH/2k10Results.htm#TabC-1. Accessed June 11, 2012.
3. Substance Abuse and Mental Health Services Administration. The Monitoring the Future Study. Vicodin: Trends in Annual Use Grades 8, 10, and 12, December 2011. Available at: www.monitoringthefuture.org/data/11data/fig11_8.pdf. Accessed June 11, 2012.
4. Code of Federal Regulations. Title 21: Food and Drugs Part 1308 Schedules of Controlled Substances 1308.12 Schedule II, June 2012. Available at: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=8a13fb1f4c0 d7fdcb908504abaec4670&rgn=div8&view=text&node=21:9.0.1.1.9.0 .26.5&idno=21. Accessed June 11, 2012.
5. Code of Federal Regulations. Title 21: Food and Drugs Part 1308 Schedules of Controlled Substances 1308.13 Schedule III, June 2012. Available at: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=8a13fb1f4c0 d7fdcb908504abaec4670&rgn=div8&view=text&node=21:9.0.1.1.9.0 .26.6&idno=21. Accessed June 11, 2012.
6. U.S. Government Printing Office (GPO). Federal Digital System. 112th Congress 2D Session S. 3187, May 24, 2012. Available at: www.gpo.gov:80/fdsys/pkg/BILLS-112s3187es/pdf/BILLS-112s3187es.pdf. Accessed June 11, 2012.
7. National Association of Boards of Pharmacy. Amendment to reclassify hydrocodone as schedule ii controlled substance passes U.S. Senate, May 2012. Available at: www.nabp.net/news/amendmentto-reclassify-hydrocodone-as-schedule-ii-cont rolled-substancepasses-us-senate/. Accessed June 11, 2012.
8. American Pharmacists Association. Senate passes Hydrocodone Rescheduling Amendment, May 2012. Available at: www.pharmacist.com/AM/Template.cfm?Section=Pharmacy_News&Template=/C M/ContentDisplay.cfm&ContentID=28562. Accessed June 11, 2012.
9. Manchin thanks senate colleagues for unanimous support of bill to help fight prescription drug abuse, May 2012. Available at: www.manchin.senate.gov/public/index/cfm/press-releases?ID=55b980c0-b9b9- 4963-a69e-66bc4ca43f8b&utm_source=BenchmarkEmail&utm_campaign=e_ News_05_30_12&utm_medium=email. Accessed June 11, 2012.
10. Code of Federal Regulations. Title 21: Food and Drugs Controlled Substances Listed in Schedule II.1306.11 Requirement of Prescription, June 2012. Available at: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=8a13fb1f4c0 d7fdcb908504abaec4670&rgn=div5&view=text&node=21:9.0.1.1.7&idno=21#21:9.0.1.1.7.0.19.10. Accessed June 11, 2012.
11. American Pharmacists Association. Opposition to rescheduling hydrocodone combination products, May 2012. Available at: www.ncpanet.org/pdf/leg/may12/hydrocodone_s.pdf. Accessed June 11, 2012.
12. Zohydro (hydrocodone bitartrate) extended release capsules. San Diego: Zogenix. Available at: www.zogenix.com/index.php/products/zx002/. Accessed June 11, 2012.
13. Schumer Reveals: New super-drug reportedly ten times as powerful and dangerous as Vicodin seeking FDA approval for introduction to marketplace. Available at: www.schumer.senate.gov/record.cfm?id=335541&. Accessed June 12, 2012.
14. ClinicalTrials.gov. Phase 3 study of hydrocodone bitartrate controlled-release capsules in subjects with chronic low back pain (HC-CR 801), May 2012. Available at: www.clinicaltrials.gov/ct2/show/NCT01081912?term=NCT01081912&rank=1. Accessed June 12, 2012.
15. Teva Pharmaceuticals plans to market hydrocodone; Abuse experts worried. Available at: www.huffingtonpost.com/2012/01/13/hydrocodone-addictive-painkiller-teva_ n_1204470.html. Accessed June 12, 2012.
16. Schneider JP, Matthews M, Jamison RN. Abuse-deterrent and tamper-resistant opioid formulations what is their role in addressing prescription opioid abuse? CNS Drugs 2010;24(10):805-810.