Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News

These brand-name medicines have caught the DEA’s attention—and those of addicts.

Following is a list of 25 branded drugs within 11 categories of prescription drugs cited by the U.S. Drug Enforcement Administration (DEA) as being “Drugs of Concern,” according to a presentation by Robert L. Hill, executive assistant in DEA’s Office of Diversion Control on April 15, 2014, and available on DEA’s website at http://www.deamuseum.org/education/transcripts/041514-RobertHill-PPT.pdf. Drugs on this list are ranked by total number of dispensed prescriptions, as included in the National Prescription Audit: Retail, Mail, and LTC, compiled by IMS Health. Drugs for which fewer than 100 prescriptions were dispensed were not listed.

Abuse of prescription drugs remains the leading cause of injury death in the United States: During 2012, according to the CDC, 41,502 drug overdose deaths were recorded. Most of them (33,175 or 79.9%) were unintentional. Another 5,465 (13.2%) were suicides, while 80 (0.2%) were homicides, and 2,782 (6.7%) were of undetermined intent.

Yet there’s reason for hope. CDC earlier this fall reported that the rate of increase for prescription-drug deaths has slowed down in recent years—up 18% each year from 1999 through 2006, but rising only 3% from 2007 through 2011. One reason why is tighter rules on the prescribing of methadone. Washington hopes to see even better results following the DEA’s reclassifying hydrocodone combination drugs from Schedule III to the stricter Schedule II—a change that took effect on October 6.


#25. Dilaudid HP (hydromorphone HCl) injection solution

Maker of brand-name drug: Purdue Pharma

2013 total dispensed prescriptions: 378

Market share: 0.01% of hydromorphone market

DEA drug classification: Schedule II

Indication: Indicated for the management of moderate-to-severe pain in opioid-tolerant patients who require higher doses of opioids.


#24. Oxecta (oxycodone HCl)

Maker of brand-name drug: Pfizer

2013 total dispensed prescriptions: 604

Market share: 0.00% of oxycodone market

DEA drug classification: Schedule II

Indication: Opioid agonist indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.


#23. Abstral (fentanyl) sublingual tablets

Maker of brand-name drug: Galena Biopharma

2013 total dispensed prescriptions: 849

Market share: 0.01% of fentanyl market

DEA drug classification: Schedule II

Indication: Opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.


#22. Lazanda (fentanyl) nasal spray

Maker of brand-name drug: Depomed

2013 total dispensed prescriptions: 1,011

Market share: 0.01% of fentanyl market

DEA drug classification: Schedule II

Indication: Opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.


#21. Vicodin (hydrocodone bitartrate and acetaminophen)

Maker of brand-name drug: AbbVie

2013 total dispensed prescriptions: 2,695

Market share: 35.93% of hydrocodone market

DEA drug classification: Schedule II

Indication: Indicated for relief of moderate to moderately severe pain.


#20. Actiq (fentanyl citrate)

Maker of brand-name drug: Cephalon (Teva Pharmaceutical Industries) oral transmucosal lozenge

2013 total dispensed prescriptions: 2,701

Market share: 0.01% of fentanyl market

DEA drug classification: Schedule II

Indication: Opioid agonist indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.


#19. Opana (oxymorphone HCl) injection

Maker of brand-name drug: Endo International

2013 total dispensed prescriptions: 2,770

Market share: 0.24% share of oxymorphone market

DEA drug classification: Schedule II

Indication: Opioid agonist indicated for the relief of moderate to severe pain. It is also indicated for preoperative medication, for support of anesthesia, for obstetrical analgesia, and for relief of anxiety in patients with dyspnea associated with pulmonary edema secondary to acute left ventricular dysfunction.


#18. Niravam (alprazolam)

Maker of brand-name drug: Pfizer

2013 total dispensed prescriptions: 4,436

Market share: 0.01% of alprazolam market

DEA drug classification: Schedule IV

Indication: Indicated for management of anxiety disorder or short-term relief of symptoms of anxiety; treatment of panic disorder, with or without agoraphobia.


#17. Dilaudid-5 (hydromorphone HCl) oral liquid

Maker of brand-name drug: Purdue Pharma

2013 total dispensed prescriptions: 6,182

Market share: 0.16% of hydromorphone market

DEA drug classification: Schedule II

Indication: Opioid analgesic indicated to help relieve moderate to severe pain. The extended-release form of this medication is for around-the-clock treatment of pain.


#16. Methadose (methadone HCl) (includes oral concentrate, sugar-free oral concentrate, dispersible tablets)

Maker of brand-name drug: Mallinckrodt

2013 total dispensed prescriptions: 8,900

Market share: 0.23% of methadone market

DEA drug classification: Schedule II

Indication: Opioid agonist indicated for management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time; detoxification treatment of opioid addiction (heroin or other morphine-like drugs); maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.


#15. Xanax XR (alprazolam) extended release tablets

Maker of brand-name drug: Pfizer

2013 total dispensed prescriptions: 13,670

Market share: 0.03% of alprazolam market

DEA drug classification: Schedule IV

Indication: Indicated for treatment of panic disorder, with or without agoraphobia; efficacy of Xanax XR beyond eight weeks has not been systematically evaluated: “The physician who elects to use this drug for periods longer than eight weeks should periodically reassess the usefulness of the drug for the individual patient.”


#14. Roxicodone (oxycodone hydrochloride) Tablets

Maker of brand-name drug: Mallinckrodt

2013 total dispensed prescriptions: 16,434

Market share: 0.07% of oxycodone market

DEA drug classification: Schedule II

Indication: Immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.


#13. Subsys (fentanyl sublingual spray)

Maker of brand-name drug: Insys Therapeutics

2013 total dispensed prescriptions: 21,112

Market share: 0.31% of fentanyl market

DEA drug classification: Schedule II

Indication: Opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients must remain on around-the-clock opioids when taking Subsys.


#12. Zubsolv (buprenorphine and naloxone) sublingual tablets

Maker of brand-name drug: Orexo U.S.

2013 total dispensed prescriptions: 24,125

Market share: 0.3% of buprenorphine/naloxone market

DEA drug classification: Schedule III

Indication: Partial-opioid agonist indicated as maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support.


#11. Soma (carisoprodol)

Maker of brand-name drug: Meda Pharmaceuticals

2013 total dispensed prescriptions: 25,829

Market share: 0.31% of carisoprodol market

DEA drug classification: Schedule IV

Indication: Indicated together with rest and physical therapy for the relief of short-term acute painful muscles and skeletal conditions in adults.


#10. Fentora (fentanyl citrate)

Maker of brand-name drug: Cephalon (Teva Pharmaceutical Industries)

2013 total dispensed prescriptions: 26,410

Market share: 0.39% of fentanyl market

DEA drug classification: Schedule II

Indication: Management of breakthrough pain in adults with cancer who are already routinely taking other opioid pain medicines around-the-clock for cancer pain.


#9. Dilaudid (hydromorphone HCl) injection solution

Maker of brand-name drug: Purdue Pharma

2013 total dispensed prescriptions: 38,465

Market share: 0.99% of hydromorphone market

DEA drug classification: Schedule II

Indication: Opioid analgesic indicated for the management of pain where an opioid analgesic is appropriate.


#8. Adderall (amphetamine/dextroamphetamine)

Maker of brand-name drug: Shire

2013 total dispensed prescriptions: 125,173

Market share: 0.52% share of amphetamine/dextroamphetamine market

DEA drug classification: Schedule II

Indication: Indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.


#7. Duragesic (fentanyl transdermal system pain patch)

Maker of brand-name drug: Janssen Pharmaceuticals (Johnson & Johnson)

2013 total dispensed prescriptions: 175,167

Market share: 2.59% of fentanyl market

DEA drug classification: Schedule II

Indication: Opioid agonist indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.


#6. Exalgo (hydromorphone HCl)

Maker of brand-name drug: Mallinckrodt

2013 total dispensed prescriptions: 235,393

Market share: 6.08% share of hydromorphone market

DEA drug classification: Schedule II

Indication: Opioid agonist indicated in opioid-tolerant patients for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.


#5. Xanax (alprazolam) tablets

Maker of brand-name drug: Pfizer

2013 total dispensed prescriptions: 239,589

Market share: 0.48% of alprazolam market

DEA drug classification: Schedule IV

Indication: Indicated for management of anxiety disorder or short-term relief of symptoms of anxiety; treatment of panic disorder, with or without agoraphobia.


#4. Opana ER (oxymorphone HCl)

Maker of brand-name drug: Endo International

2013 total dispensed prescriptions: 756,318

Market share: 66.18% share of oxymorphone market

DEA drug classification: Schedule II

Indication: Opioid agonist for the relief of moderate to severe pain in patients requiring continuous around-the-clock opioid treatment for an extended period of time.


#3. Adderall XR (amphetamine/dextroamphetamine)

Maker of brand-name drug: Shire

2013 total dispensed prescriptions: 3,052,106

Market share: 12.78% share of amphetamine/dextroamphetamine market

DEA drug classification: Schedule II

Indication: CNS stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD).


#2. OxyContin (Oxycodone HCl controlled-release)

Maker of brand-name drug: Purdue Pharma

2013 total dispensed prescriptions: 5,659,272

Market share: 25.59% of oxycodone market

DEA drug classification: Schedule II

Indication: Indicated for treating moderate to severe pain in patients who require around-the-clock opioids for an extended time.


#1. Suboxone (buprenorphine and naloxone) sublingual film

Maker of brand-name drug: Reckitt Benckiser Pharmaceuticals

2013 total dispensed prescriptions: 7,157,349

Market share: 88.86% of buprenorphine/naloxone market

DEA drug classification: Schedule III

Indication: Partial-opioid agonist indicated as maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support.

















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