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Modest Growth Seen in Epilepsy Market

Kunj Gohil PharmD, RPh
Devin Enhoffer PharmD, RPh

Epilepsy is a disorder of the central nervous system that affects signaling between the nerves within the brain.1 Impairment in normal conduction can result in a seizure in which a patient experiences a range of symptoms from abnormal sensations to loss of consciousness.2,3 In 2012, approximately 17.5 million patients suffered from epilepsy around the world, with 2.2 million from the United States; this figure is expected to grow to 18.7 million patients globally, and 2.45 million patients in the U.S., by 2022.4

The epilepsy market has undergone many changes since 2008 with the loss of patent protection for blockbuster drugs. The global market yielded $4.2 billion in sales in 2012, with $2.0 billion of those sales in the U.S. The introduction of novel antiepileptic drugs and increased access to therapies is expected to drive market growth. By 2022, global sales are expected to rise to $5.4 billion, with more than 50%, or $2.7 billion, of those sales in the U.S.4

Although the market is extremely crowded with branded and generic drugs, pharmaceutical companies have shifted their focus to developing safe adjunctive therapies for refractory patients.4 Currently, brivaracetam is the only drug in phase 3 testing for the treatment of epilepsy. This experimental medication recently reduced seizure frequency and improved response rates in patients over a 12-week period.5 The drug’s manufacturer hopes to file for FDA approval soon, and analysts expect approval by 2015.4,5

Tables

Future Therapies: Promising Drugs
DrugManufacturer Status Regimen Information Pivotal Studies Expected Approval Anticipated Peak Year Sales/Pricing
Brivaracetam
UCB
Phase 3 50–200 mg/day NCT00175916
NCT00761774
NCT00504881
NCT01728077
2015 Will likely be priced similarly to Vimpat, the latest AED from UCB; anticipated global sales of $582.8M in 2022 (U.S., $486.4M)
Ganaxolone
Marinus Pharmaceuticals
Phase 2b 1,500 mg/day NCT01002820
NCT00465517
2019 Will likely be priced at a 10% premium over recently launched AEDs Potiga and Fycompa due to its novel MOA; anticipated global sales of $47.8M (U.S., $43.2M)
VX-765
Vertex Pharmaceuticals
Phase 2b 900 mg/day NCT01501383 2019 Will likely be priced at a 10% premium over recently launched AEDs Potiga and Fycompa due to its novel MOA; anticipated global sales of $27.4M (U.S., $24.7M)
Future Therapies: Early Stage
YKP3089
SK Biopharmaceuticals
Phase 2 Low, medium, or high dose NCT01866111
NCT01397968
After 2022 Will likely be priced similarly to current AEDs at time of approval
ICA-105665
Icagen/Pfizer
Phase 2 100–600 mg/day NCT00979004 After 2022 Will likely be priced similarly to current AEDs at time of approval
Carisbamate
SK Biopharmaceuticals
Phase 2 400–1,200 mg/day NCT00991757
NCT00425282
NCT00433667
After 2022 Will likely be priced similarly to current AEDs at time of approval
Naluzotan
Proximagen Group/NINDS
Phase 2 240 mg/day NCT01281956 After 2022 Will likely be priced similarly to current AEDs at time of approval

AED = antiepileptic drug; M = millions; MOA = mechanism of action

Sources: Global Data, ClinicalTrials.gov

Selected Current Therapiesa
Drug
Manufacturer
Approval Date Indicationb Regimen Informationc Cost of Course of Therapy per Yeard
Aptiom (eslicarbazepine acetate)
Sunovion Pharmaceuticals
November 8, 2013 (tablet) Adjunctive therapy, epilepsy (age 18 years and older) 800–1,200 mg/day once daily $14,585–$21,878
Fycompa (perampanel)
Eisai
October 22, 2012 (tablet) Adjunctive therapy, epilepsy (age 12 years and older) 4–12 mg/day once daily at bedtime $6,920–$20,761
Potiga (ezogabine)
GlaxoSmithKline
June 10, 2011 (tablet) Adjunctive therapy, epilepsy (age 18 years and older) 600–1,200 mg/day in divided doses $6,239–$12,479
Banzel (rufinamide)
Eisai
November 14, 2008 (tablet) Adjunctive therapy, epilepsy (Lennox-Gastaut syndrome) (age 4 years and older) 400–3,200 mg/day in divided doses $4,526–$36,208
Vimpat (lacosamide)
UCB
October 28, 2008 (tablet) Adjunctive therapy, epilepsy (age 17 years and older) 200–400 mg/day in divided doses $3,730–$7,460
Lyrica (pregabalin)
PF Prism and CP Pharms
December 30, 2004 (capsule) Adjunctive therapy, epilepsy (age 18 years and older); fibromyalgia, neuropathic pain (associated with diabetic peripheral neuropathy or spinal cord injury); postherpetic neuralgia 150–600 mg/day in divided doses $1,601–$6,405
Zonegran (zonisamide)*
Eisai
March 27, 2000 (capsule) Adjunctive therapy, epilepsy (age 16 years and older) 100–600 mg/day in divided doses $2,376–$14,257 (generic, $122–$730)
Trileptal (oxcarbazepine)*
Novartis
January 14, 2000 (tablet) Adjunctive therapy, epilepsy (age 2 years and older); monotherapy, epilepsy (age 4 years and older) 2,400 mg/day in divided doses $12,258 (generic, $1,022)
Keppra (levetiracetam)*
UCB
November 30, 1999 (tablet) Adjunctive therapy, epilepsy (age 1 month and older) 3,000 mg/day in divided doses $13,804 (generic, $719)
Keppra XR (levetiracetam XR)
UCB
November 30, 1999 (tablet) Adjunctive therapy, epilepsy (age 12 years and older) 1,000–3,000 mg/day once daily $4,171–$12,514
Topamax (topiramate)*
Janssen
December 24, 1996 (tablet) Adjunctive therapy, epilepsy (age 2 years and older); monotherapy, epilepsy (age 2 years and older); migraine prophylaxis (age 12 years and older) 400 mg/day in divided doses $9,253 (generic, $110)
Lamictal (lamotrigine)*
GlaxoSmithKline
December 27, 1994 (tablet) Adjunctive therapy, epilepsy (age 2 years and older); monotherapy, epilepsy (age 16 years and older); bipolar disorder (age 18 years and older) 225–375 mg/day in divided doses $8,887–$17,388 (generic, $73–$142)
Neurontin (gabapentin)*
Pfizer
December 30, 1993 (capsule) Adjunctive therapy, epilepsy (age 3 years and older); postherpetic neuralgia 300–600 mg/day 3 times a day $3,077– $6,153 (generic, $77–$153)

*Generic available

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 are 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 wholesale acquisition cost and regimen provided and rounded to the nearest dollar

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

References

  1. National Institute of Neurological Disorders and Stroke. NINDS epilepsy information page. August 2014;Available at: http://www.ninds.nih.gov/disorders/epilepsy/epilepsy.htm. Accessed October 8, 2014
  2. Centers for Disease Control and Prevention. Epilepsy. September 2014;Available at: https://www.cdc.gov/epilepsy/. Accessed October 8, 2014
  3. Mayo Clinic. Epilepsy: treatment and drugs. May 2013;Available at: https://www.mayoclinic.org/diseases-conditions/epilepsy/diagnosis-treatment/treatment/txc-20117241. Accessed October 8, 2014
  4. GlobalData. Epilepsy—Global Drug Forecast and Market Analysis to 2022—Event-Driven Update December 2013;
  5. Garde D. UCB inches toward the FDA with its latest epilepsy contender. Fierce Biotech July 232014;Available at: https://www.fiercebiotech.com/r-d/ucb-inches-toward-fda-its-latest-epilepsy-contender. Accessed October 8, 2014