Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News

As Overdose Deaths Continue to Soar, Contributors Go Beyond Opioids

When it comes to drugs of abuse, public attention and news headlines continue to focus on opioid addiction: In August, the Intermountain Healthcare hospital chain announced it would reduce the number of opioids it prescribes by 40% or 5 million pills by the end of 2018, while Bloomberg reported on the growing numbers of states, local governments, and prominent lawyers pursuing litigation against opioid makers and distributors.

Also in August, the U.S. Centers for Disease Control and Prevention (CDC)’s National Center for Health Statistics published provisional figures based on available data showing a record-high of 64,070 drug overdose deaths in the 12 months ending in January 2017—up 21% from the 52,898 drug overdose deaths reported for 2015. Of the 2016 overdose deaths, a total 83% involved drugs in any of four opioid classes: Heroin, natural and semi-synthetic opioids, methadone, and other synthetic opioids.

Yet the number and variety of abused drugs goes beyond opioids. In this year’s edition of “Drugs of Abuse,” as in past years, the U.S. Drug Enforcement Administration (DEA) has included opioids among narcotics—one of several classes of drugs included in the report along with stimulants, depressants, hallucinogens, marijuana/cannabis, steroids, inhalants, designer drugs, and other “drugs of concern.”

The DEA’s report identified categories of abused prescription drugs—plus many examples of the brand name drugs within the categories)—for which sales data was available through marketers of the drugs (for branded drugs) or through Evaluate™, the service that tracks industry sales figures for many of the branded drugs as well as other drugs within the same category. These categories typically include a branded drug, branded generics, and/or just regular generics made by manufacturers that furnish data to Evaluate.

Brand name drug sales figures on this list include those disclosed by public drug makers in 10-Qs, 10-Ks and/or press releases. For one drug—Celecox, marketed by Astellas Pharma—GEN compiled full-calendar-year 2016 data by adding quarterly results from Astellas (which usually compiles annual data in an April-to-March fiscal year, in order to maintain consistency with the full-year figures reported by other drug companies).

This year as last, GEN lists the top 20 abused prescription drugs ranked by 2016 sales as furnished either by marketers of the drug or by Evaluate. Compared to GEN’s 2016 list, the numbers recorded this year prompt two observations that may prove, with further study, to be significant factors in explaining the overall record-setting pace of overdose deaths.

One observation is that increasing generic competition has reduced overall sales for most categories of abused drugs. Fifteen of the 20 drugs on this year’s list showed sales decreases—possibly because the lower price of generics increases its availability to potential addicts.

Another finding is that this year’s figures also showed sales increases for four brand-name drugs and one category on this list. These include ADHD treatments Adderall XR® and Concerta®. Sales for drugs treating attention disorders have been projected to more than double to $13.9 billion by 2024, from $6.1 billion in 2014, according to GlobalData—which cited convenient oral formulations, less frequent dosing, rising treatment rates, and continued awareness and recognition of ADHD among adults as factors that will drive sales increases. The trend of rising use of attention deficit hyperactivity disorder (ADHD) medications was chronicled in 2014 in Express Scripts’ Drug Trend Report.

Included as well is arthritis treatment Celecox®, Astellas’ branded celecoxib drug in Japan, where patent protection continues till 2019. Also showing a sales gain were opioid dependence treatment Suboxone® and its category of buprenorphine and naloxone. The combination consists of buprenorphine—a semisynthetic opioid that works as a partial µ-opioid receptor agonist and a κ-receptor antagonist—with naloxone, an opioid antagonist used for reversing overdoses. Last year, President Barack Obama signed into law S.524, the Recovery Enhancement for Addiction Treatment Act, which expanded access by states to buprenorphine and naloxone—a potential factor in increased 2016 sales. S.524, the Recovery Enhancement for Addiction Treatment Act


#20. Morphine sulfate

Category includes morphine sulfate oral (Mallinckrodt), Morphine QD (Allergan), Avinza (Pfizer), morphine sulfate (Pfizer and its Hospira subsidiary), morphine sulfate ER (Endo International), MS Contin (Purdue Pharma and Shionogi), Statex (Endo International and Paladin Labs), morfin bioglan (Meda), and morphine sulfate I.V. (Allergan)

2016 sales: $132 million, according to Evaluate

2015 sales: $259 million, according to Evaluate

% Change: -49.0%

DEA drug classification: Schedule II

Indications: Opioid agonist indicated for the management of pain not responsive to nonnarcotic analgesics.


#19. Subsys (fentanyl sublingual spray; marketed by Insys Therapeutics)

Brand-name drug.

2016 sales: $242.275 million, according to Insys Therapeutics 1

2015 sales: $327.020 million, according to Insys Therapeutics 2

% Change: -25.9%

DEA drug classification: Schedule II

Indications: Drug-in-adhesive matrix formulation indicated for 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.


#18. Ritalin®/Focalin (methylphenidate HCl; marketed by Novartis)

Brand-name drug; includes Ritalin-SR® sustained-release tablets and Ritalin LA® extended-release capsules.

2016 sales: $282 million, according to Novartis

2015 sales: $365 million, according to Novartis

% Change: -22.7%

DEA drug classification: Schedule II

Indication: Mild CNS stimulant indicated for attention-deficit disorders. Indicated as an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms—moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.


(tie) #16. Duragesic (fentanyl transdermal system) for transdermal administration, CII (marketed by Jansen Pharmaceuticals (Johnson & Johnson)

Brand-name drug.

2016 sales: $288 million, according to Evaluate

2015 sales: $334 million, according to Evaluate

% Change: -13.8%

DEA drug classification: Schedule II

Indications: Drug-in-adhesive matrix formulation indicated for 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.


(tie) #16. Methylphenidate ER (LA; marketed by Allergan)

Authorized generic version.

2016 sales: $288 million, according to Evaluate

2015 sales: $665 million, according to Evaluate

% Change: -56.7%

DEA drug classification: Schedule II

Indications: CNS stimulant used for the treatment of ADHD.


#15. Zoloft (sertraline HCl)

Brand-name drug marketed by Pfizer.

2016 sales: $304 million, according to Pfizer

2015 sales: $374 million, according to Pfizer

% Change: -18.7%

DEA drug classification: Not scheduled

Indications: Selective serotonin reuptake inhibitor indicated for major depressive disorder in adults.


#14. Hydromorphone HCl

Category iIncludes Exalgo (Johnson & Johnson and Mallinckrodt), as well as hydromorphone hydrochloride ER (Allergan) and hydromorphone hydrochloride (Pfizer and its Hospira subsidiary, Akorn). Does not include Dilaudid (Purdue Pharma), hydromorphone hydrochloride, 16-mg extended-release tablets (Mallinckrodt); or hydromorphone hydrochloride, 3-mg suppositories or 12-mg extended-release tablets (Perrigo).

2016 sales: $316 million, according to Evaluate

2015 sales: $368 million, according to Evaluate

% Change: -14.1%

DEA drug classification: Schedule II

Indications: Pure opioid agonist indicated for the management of pain in patients where an opioid analgesic is appropriate.


#13. Sertraline HCL

Category includes Zoloft (Pfizer), which is listed separately, as well as Sertraline (Lupin and Teva Pharmaceutical Industries), and Stimuloton (Servier). Does not include Stimuloton (Egis Pharmaceuticals).

2016 sales: $349 million, according to Evaluate

2015 sales: $417 million, according to Evaluate

% Change: -16.3%

DEA drug classification: Not scheduled

Indications: Selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder in adults.


#12. Ambien® (also sold as Myslee® and Stilnox® by Sanofi; zolpidem tartrate)

Brand-name drug; includes Ambien CR® (zolpidem tartrate extended-release tablets).

2016 sales: €304 million ($362.5 million), according to Sanofi

2015 sales: €306 million ($366.5 million), according to Sanofi 3

% Change: -0.7%

DEA drug classification: Schedule IV

Indications: Gamma-aminobutyric acid (GABA) A agonist indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien CR is indicated for treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.


#11. Adderall XR® (amphetamine/dextroamphetamine)

Brand-name drug marketed by Shire.

2016 sales: $363.8 million, according to Shire

2015 sales: $362.8 million, according to Shire

% Change: 0.3%

DEA drug classification: Schedule II

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


#10. Celecox (celecoxib)

Brand-name drug marketed in Japan by Astellas Pharma.

2016 sales: ¥47.4 billion ($434.5 million), according to Astellas Pharma

2015 sales: ¥46.2 billion ($423.5 million), according to Astellas Pharma 4

% Change: 2.6%

DEA drug classification: Not scheduled

Indications: Nonsteroidal anti-inflammatory drug indicated for the treatment of rheumatoid arthritis, osteoarthritis, low back pain, periarthritis scapulohumeralis, and neck, shoulder, and arm syndrome or tendonitis/tenosynovitis with anti-inflammatory/analgesic effects. It is also used to reduce inflammation and pain after operation, traumatic injuries, or tooth removal.


#9. Zolpidem tartrate

Category includes Ambien (Sanofi), which is listed separately, as well as Myslee (Astellas Pharma), Sublinox (Valeant Pharmaceuticals International). Does not include Zolpidem Tartrate Extended-Release Tablets, marketed by Par Pharmaceuticals, a subsidiary of Endo International, in 6.25-mg and 12.5-mg dosages.

2016 sales: $491 million, according to Evaluate

2015 sales: $558 million, according to Evaluate

% Change: -12.0%

DEA drug classification: Schedule IV

Indications: GABA A agonist indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. 


#8. Fentanyl

Category includes Duragesic, which is listed separately, as well as Fentanyl Transdermal System (Mylan, Allergan, and Teva Pharmaceutical Industries), Fentanyl Transdermal System Patch (Mallinckrodt), and Fentanyl Patch (STADA Arzneimittel).

2016 sales: $560 million, according to Evaluate

2015 sales: $719 million, according to Evaluate

% Change: -22.1%

DEA drug classification: Schedule II

Indications: Fentanyl transdermal patches are indicated for management of persistent, moderate-to-severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time and cannot be managed by other means, such as nonsteroidal analgesics, opioid combination products, or immediate-release opioids. 


#7. Celebrex (celecoxib capsule; marketed by Pfizer)

Brand-name drug.

2016 sales: $733 million, according to Pfizer

2015 sales: $830 million, according to Pfizer

% Change: -11.7%

DEA drug classification: Not scheduled

Indications: Nonsteroidal anti-inflammatory drug indicated for osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis in patients two years and older, ankylosing spondylitis, acute pain in adults, and primary dysmenorrhea.


#6. Concerta (methylphenidate HCl; marketed by Janssen Pharmaceuticals (Johnson & Johnson)

Brand-name drug.

2016 sales; $863 million, according to Johnson & Johnson

2015 sales: $821 million, according to Johnson & Johnson

% Change: 5.1%

DEA drug classification: Schedule II

Indications: CNS stimulant indicated for the treatment of ADHD in children six years of age and older, adolescents, and adults up to the age of 65.


#5. Suboxone® (buprenorphine and naloxone; sublingual film, for sublingual or buccal use, marketed by Indivior)

Brand-name drug.

2016 sales: $935 million, according to Evaluate

2015 sales: $808 million, according to Evaluate

% Change: 15.7%

DEA drug classification: Schedule III

Indications: Partial-opioid agonist indicated as maintenance treatment of opioid dependence that should be used as part of a complete treatment plan to include counseling and psychosocial support.


#4. Buprenorphine and naloxone

Category includes Suboxone film (Indivior), which is listed separately, as well as Zubsolv (Orexo), buprenorphine/naloxone (Allergan), buprenorphine hydrochloride and naloxone hydrochloride (Teva Pharmaceutical Industries), and Bunavail (BioDelivery sciences International).

2016 sales: $1.026 billion, according to Evaluate

2015 sales: $892 million, according to Evaluate

% Change: 15.0%

DEA drug classification: Schedule III

Indications: Buprenorphine is an opioid partial agonist; naloxone is an opioid antagonist. Combination is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.


#3. Celecoxib

Category includes Celebrex (Pfizer), which is also listed separately, as well as Celecox (Astellas Pharma) and celecoxib (Mylan, Allergan, and Teva Pharmaceutical Industries).

2016 sales: $1.246 billion, according to Evaluate

2015 sales: $1.428 billion, according to Evaluate

% Change: -12.7%

DEA drug classification: Not scheduled

Indication: Nonsteroidal anti-inflammatory drug indicated for osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis in patients 2 years and older, ankylosing spondylitis, acute pain in adults, and primary dysmenorrhea.


#2. OxyContin (oxycodone HCl controlled-release; marketed by Purdue Pharma)

Brand-name drug.

2016 sales: $1.390 billion, according to Evaluate

2015 sales: $1.583 billion, according to Evaluate

% Change: -12.2%

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. Methylphenidate HCl

Category includes Concerta (Janssen Pharmaceuticals) and Ritalin/Focalin (Novartis), which are also listed separately, as well as methylphenidate ER (Allergan, Mallinckrodt, and Teva Pharmaceutical Industries), Metadate CD/Equasym XL (UCB), Daytrana (Hisamitsu Pharmaceutical), Quillivant XR (Pfizer), Equasym XL (Shire), and methylphenidate hydrochloride (Allergan and IMPAX Laboratories).

2016 sales: $2.073 billion, according to Evaluate

2015 sales: $2.232 billion, according to Evaluate

% Change: -7.1%

DEA drug classification: Schedule II

Indication: Used almost exclusively for the treatment for ADHD in children. Can be used legitimately in the treatment of excessive daytime sleepiness associated with narcolepsy.






















References
1 According to the company’s Form 10-K for 2016, “During the year ended December 31, 2016, all of our net revenues were generated from the sale of our approved product, Subsys®”
2 According to the company’s Form 10-K for 2015, During the year ended December 31, 2015, sales of Subsys accounting for “over 99%” of 2015 revenues, which were reported as $330.797 million, and later revised to $330.323 million to correct an accounting error.
3 2015 sales figure differs from $346 million figure published by GEN last year due to currency fluctuations since then.
4 2015 sales figure differs from $433.5 million figure published by GEN last year due to currency fluctuations since then.

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