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Major Depressive Disorder

New Products Are Facing a Saturated Market
Kunj Gohil PharmD, RPh
Palak Shah PharmD, RPh

Major depressive disorder (MDD) is a serious condition that can affect patients’ ability to sleep, work, eat, and go about their lives.1 This extremely complex disease is poorly under stood and is thought to be caused by both genetic and environmental factors. Its development is associated with numerous neurotransmitter abnormalities, including serotonin, norepinephrine, and dopamine, among others.2

The disease is fairly common today, with a prevalence of approximately 32 million patients globally in 2013; only 12 million of those patients were actively seeking treatment.2

Despite its serious signs and symptoms, MDD can be improved dramatically through pharmacological intervention. MDD treatment has created a saturated market, with medications targeting numerous mechanisms of action, and this market is expected to grow more crowded in the coming years.4 In 2013, drug sales yielded $9.3 billion globally, with the U.S. accounting for $7.5 billion; this is expected to reach $9.7 billion globally and $7.6 billion in the U.S. by 2023.3

The MDD market of the future will be filled with new therapies targeting key unmet needs, such as increased efficacy, a safer profile, and a faster onset of action. Manufacturers hope to use novel mechanisms of action to improve drug profiles and help patients to better manage this disease.3

Tables

Future Therapies

Drug
Manufacturer
Status Regimen Information Pivotal Studies Expected Approval Anticipated Peak Year Sales/Pricing
Brexpiprazole
Otsuka/Lundbeck
NDA filed Up to 3 mg/day orally NCT01360645
NCT01360632
NCT00797966
Q2 2015 Brexpiprazole will likely be priced similarly to Abilify; US sales $529 million by 2023
Cariprazine
Forest (Actavis)/Gedeon Richter
NDA filed Up to 4.5 mg/day orally NCT01838876
NCT00854100
NCT01469377
Q2 2015 Cariprazine will likely be priced similarly to Abilify and Seroquel XR; US sales $322 million by 2023
ALKS-5461
Alkermes
Phase 3 Up to 2 mg/day orally FORWARD program 2017 ALKS-5461 will likely be priced approximately 10% higher than Abilify and Seroquel XR; US sales $1.23 billion by 2023
Amitifadine
Euthymics Bioscience
Phase 3 Up to 100 mg/day orally (efficacy dose yet to be determined) TRIADE program 2018 Amitifadine will likely be priced similarly to branded SNRIs; US sales $493 million by 2023
GLYX-13
Naurex
Phase 3 Up to 10 mg/kg intravenously (frequency unknown) NCT01684163 2018 GLYX-13 will likely be priced 20%–30% higher than other adjunctive treatments; US sales $227 million by 2023
Tedatioxetine
Lundbeck/Takeda
Phase 2b 10 mg/day or 20 mg/day orally NCT00599911 2018 Tedatioxetine will likely be priced similarly to Brintellix; US sales $335 million by 2023
ETS6103
e-Therapeutics
Phase 2b 20 mg/day (low dose) or 70 mg/day (high dose) orally NCT02014363 2020 ETS6103 will likely be priced similarly to branded second-line treatments; US sales $66 million by 2023

NDA = new drug application; Q2 = quarter two; SNRIs = serotonin–norepinephrine reuptake inhibitors; US = United States

Sources: FDA; GlobalData; company websites; ClinicalTrials.gov

Current Therapiesa

Drug
Manufacturer
Approval Date Indicationb Regimen Informationc Cost of Course of Therapy per Yeard
Multimodal Antidepressant
Brintellix (vortioxetine)
Lundbeck/Takeda
September 30, 2013 Treatment of MDD 20 mg daily orally $3,499
Selective Serotonin Reuptake Inhibitors
Viibryd (vilazodone)
Forest (Actavis)
January 21, 2011 Treatment of MDD 40 mg daily orally $2,767
Lexapro (escitalopram)
Lundbeck/Forest (Actavis)
August 14, 2002 Acute and maintenance treatment of MDD in adults and adolescents ages 12–17 years 10 mg daily orally $2,942 (generic, $1,554)
Celexa (citalopram)
Forest (Actavis)
July 17, 1998 Treatment of MDD 20 mg daily orally $2,535 (generic, $50)
Paxil (paroxetine)
Apotex Technologies
December 29, 1992 Treatment of MDD 20 mg daily orally $2,184 (generic, $964)
Zoloft (sertraline)
Pfizer
December 30, 1991 Treatment of MDD 50 mg daily orally $2,743 (generic, $986)
Prozac (fluoxetine)
Eli Lilly
December 29, 1987 Acute and maintenance treatment of MDD 20 mg daily orally $3,916 (generic, $18)
Serotonin–Norepinephrine Reuptake Inhibitors
Fetzima (levomilnacipran)
Forest (Actavis)/Pierre Fabre
July 25, 2013 Treatment of MDD 40 mg to 120 mg daily orally $3,456
Pristiq (desvenlafaxine)
Pfizer
February 29, 2008 Treatment of MDD 50 mg daily orally $3,381
Cymbalta (duloxetine)
Eli Lilly
August 3, 2004 Treatment of MDD 60 mg daily orally $3,184 (generic, $730)
Venlafaxinee December 28, 1993 Treatment of MDD 75 mg daily orally Generic, $798
Norepinephrine–Dopamine Reuptake Inhibitors
Wellbutrin (buproprion)
GlaxoSmithKline
December 30, 1985 Treatment of MDD 200 mg daily orally $2,590 (generic, $350)
Tetracyclic Antidepressants
Remeron (mirtazapine)
Merck & Co.
June 14, 1996 Treatment of MDD 15 mg daily orally $2,185 (generic, $117)
Monoamine Oxidase Inhibitors
Emsam (selegiline)
Somerset
February 27, 2006 MDD 6 mg per 24 hours via transdermal system $17,498
Nardil (phenelzine)
Parke Davis
June 9, 1961 Treatment of atypical, nonendogenous, or neurotic depression 15 mg three times a day orally $1,872 (generic, $914)
Parnate (tranylcypromine)
Covis Pharmaceuticals
February 21, 1961 Treatment of MDD, involutional melancholia, reactive depression, and psychoneurotic depression of moderate to severe intensity 20 mg daily orally $5,160 (generic, $2,365)
Marplan (isocarboxazid)
Validus Pharmaceuticals
July 1, 1959 Treatment of MDD 10 mg two times a day orally $3,451
Tricyclic Antidepressants
Tofranil (imipramine)
Mallinckrodt
May 22, 1984 MDD, childhood enuresis 50 mg to 150 mg daily orally $3,979–$11,937 (generic, $422–$1,267)
Amoxapinee September 22, 1980 Treatment of neurotic, reactive, endogenous, and psychotic depression 200 mg to 300 mg daily orally Generic, $1,086–$1,629
Surmontil (trimipramine)
Odyssey Pharmaceuticals
June 12, 1979 MDD 75 mg to 300 mg daily orally $4,376–$11,482
Pamelor (nortriptyline)
Mallinckrodt
August 1, 1977 MDD 75 mg to 100 mg daily orally $14,077–$27,623 (generic, $104–$150)
Protriptylinee September 27, 1967 MDD 20 mg to 60 mg daily orally Generic, $1,927–$5,782
Norpramin (desipramine)
Sanofi Aventis US
November 20, 1964 Treatment of depression 100 mg to 200 mg daily orally $2,562–$5,125 (generic, $1,551–$3,102)
Amitriptylinee April 7, 1961 MDD 75 mg daily orally Generic, $391

aThis list is not all-inclusive; additional therapies may be available for this disease state.

bAbbreviated indication provided; for full indication, please refer to prescribing information.

cRegimens based on the recommended dosage and maintenance phases from prescribing information; typical doses and titration schedules may vary based on patient-specific requirements.

dCosts calculated using average wholesale price and regimen provided and rounded to the nearest dollar.

eThe brand-name version of this medication has been discontinued.

Sources: Red Book; Drugs@FDA; and prescribing information for all medications

MDD = major depressive disorder

Author bio: 
Dr. Gohil is Central Services Manager with Medical Services at MediMedia Managed Markets in Yardley, Pennsylvania. Dr. Shah is a consultant for Medical Services at Medi-Media Managed Markets.

References

  1. National Institute of Mental Health Depression. Available at: https://www.nimh.nih.gov/health/topics/depression/index.shtml. Accessed January 18, 2015.
  2. WebMD. Causes of depression. February 2014;Available at: https://www.webmd.com/depression/guide/causes-depression. Accessed January 18, 2015.
  3. GlobalData. Major Depressive Disorder—Global Drug Forecast and Market Analysis to 2023 May 2014;
  4. DiPiro J, Talbert RL, Yee G, et al. Major depressive disorder. Pharmacotherapy: A Pathophysiologic Approach 9th edNew York, New York: McGraw-Hill. 2014;1047–1066.