Nuedexta

Manufacturer 

 

Otsuka Holdings                                                  $21.38 Billion
Nuedexta
Avanir Pharmaceuticals                                     $N/A

 

FDA Approval 

 

Nuedexta                                                    NDA 021879                           October 29, 2010
 
Generics                                                      Actavis Elizabeth                   October 10, 2017

 

 

MDL Information 

 

No information at this time

Background

Originally introduced and approved by the FDA as Zenvia in 2010, Avanir Pharmaceuticals renamed the drug to Nuedexta.
 
A report by CNN claims that sales of Nuedexta increased five-fold to $300m in 2018 as a result of the mis-prescribing, with around half those revenues coming from use of the drug in elderly care facilities.
 
According to MedPage Today, Dextromethorphan-quinidine (Nuedexta), approved by the FDA for pseudobulbar affect based on studies in patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS), appeared to be prescribed primarily for patients with other underlying disorders, an analysis of insurance records found.
 
Few patients who received the drug had a diagnosis of MS (8.4%) or ALS (6.8%); most (57%) had a diagnosis of dementia or Parkinson's disease, reported Aaron Kesselheim, MD, JD, MPH, of Brigham and Women's Hospital in Boston, and co-authors in JAMA Internal Medicine.
 
Otsuka paid $3.5bn to acquire Avanir in 2014 as part of a strategy to expand its presence in the central nervous system (CNS) disease category in the US. At the time, it said AVP-786 (second-generation version of Nuedexta) was one of the main attractions of the business.
Shares in the Japanese company plunged 14% in the wake of the new trial announcement, while Concert Pharmaceuticals – which out-licensed the drug to Avanir – was also hit hard.
 
Based upon reports, a more than 15-fold increase in the number of patients prescribed Nuedexta from 2011 to 2016 — 3,296 to 50,402, respectively – was also found. Likewise, the reported spending by Centers for Medicare & Medicaid Services on Nuedexta increased from $3.9 million in 2011 to $200.4 million in 2016, the study found.

 

 

Treatment / Use

 
According to Drugs.com, Nuedexta is the first and only FDA-approved treatment for pseudobulbar affect (PBA). Nuedexta is an innovative combination of two well-characterized components; dextromethorphan hydrobromide (20 mg), the ingredient active in the central nervous system, and quinidine sulfate (10 mg), a metabolic inhibitor enabling therapeutic dextromethorphan concentrations. Nuedexta acts on sigma-1 and NMDA receptors in the brain, although the mechanism by which Nuedexta exerts therapeutic effects in patients with PBA is unknown.
 
 
Nuedexta is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurological conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the patient's underlying emotional state. Studies to support the effectiveness of Nuedexta were performed in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). Nuedexta has not been shown to be safe and effective in other types of emotional lability that can commonly occur, for example, in Alzheimer's disease and other dementias. The primary outcome measure, laughing and crying episodes, was significantly lower in the Nuedexta arm compared to placebo. The secondary outcome measure, the Center for Neurologic Studies Lability Scale (CNS-LS), demonstrated a significantly greater mean decrease in CNS-LS score from baseline for the Nuedexta arm compared to placebo.

Injuries / Complications / Concerns

 
Between October 2011 and April 2016, Dr. Raheja wrote 10,088 prescriptions for Nuedexta, the most of any doctor in the country, according to prosecutors.
 
 
There have been reports of adverse events including falls and deaths associated with Nuedexta.

Information on the Topic of Nuedexta

 

Strange Disease (2-5-2020)

https://www.courthousenews.com/strange-disease/

 

Cuyahoga County, OH Complaint (2-4-2020)

https://www.courthousenews.com/wp-content/uploads/2020/02/Strange-disease.pdf

 

Mayfield Doctor Agrees to Cooperate with Feds in Probe into Neurological Drug’s Marketing (1-20-2020)

https://www.cleveland.com/court-justice/2020/01/mayfield-doctor-agrees-to-cooperate-with-feds-in-probe-into-neurological-drugs-marketing.html

 

Avanir Pharmaceuticals Will Pay Over $108 Million to Resolve Illegal Kickback Allegations Involving Its Drug Nuedexta, Three Whistleblowers Will Share $17 Million Award (10-3-2019)

https://www.whistleblowergov.org/healthcare-and-pharma.php?article=avanir-pharmaceuticals-will-pay-over-108m-to-resolve-illegal-kickback-allegations-involving-its-drug-nuedexta_160

Avanir Settles One Kickback Suit, Agrees to Cooperate in Another (10-3-2019)

https://www.policymed.com/2019/10/avanir-settles-one-kickback-suit-agrees-to-cooperate-in-another.html

 

Avanir’s Week Goes from Bad to Worse with Alzheimer’s Stumble (10-1-2019)

http://www.pmlive.com/pharma_news/avanirs_week_goes_from_bad_to_worse_with_alzheimers_stumble_1311531

 

Drug Co Admits to Kickback Scheme Involving Seniors and Nuedexta (9-27-2019)

https://www.medscape.com/viewarticle/919113

 

Cashing in on Dementia Patients: Drugmaker to Pay $116 Million in Fraud Settlement (9-26-2019)

https://www.cnn.com/2019/09/26/health/nuedexta-avanir-doj-settlement-invs/index.html

 

U.S. DOJ – Pharmaceutical Company Targeting Elderly Victims Admits to Paying Kickbacks, Resolves Related False Claims Act Violations (9-26-2019)

https://www.justice.gov/usao-ndga/pr/pharmaceutical-company-targeting-elderly-victims-admits-paying-kickbacks-resolves

Drugmaker that Pushed Pill on Elderly Now Facing Fines (2-13-2019)

https://www.cnn.com/2019/02/13/health/nuedexta-doj-investigation-invs/index.html

 

Nuedexta Often Used to Treat Symptoms of Parkinson’s and Dementia Off-label, Study Finds (1-14-2019)

https://parkinsonsnewstoday.com/2019/01/14/nuedexta-often-prescribed-to-parkinsons-and-dementia-patients-study-finds/

 

Study Raises Questions on Nuedexta Prescribing (1-7-2019)

https://www.medpagetoday.com/neurology/dementia/77282

 

Assessment of Use of Combined Dextromethorphan and Quinidine in Patients With Dementia or Parkinson Disease After US Food and Drug Administration Approval for Pseudobulbar Affect (1-7-2019)

https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2720138

 

Government Issues Warning about Pill Pushed on the Elderly (6-5-2018)

https://www.cnn.com/2018/06/04/health/nuedexta-government-warning-insurers-invs/index.html

Drugmaker Paid Doctors with Problem Records to Promote its Pill (12-4-2017)

https://www.cnn.com/2017/12/04/health/nuedexta-doctors-payments-invs/index.html

 

The Little Red Pill Being Pushed on the Elderly (10-12-2017)

https://www.cnn.com/2017/10/12/health/nuedexta-nursing-homes-invs/index.html

 

Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA) (PRISM II) (3-15-2017)

https://clinicaltrials.gov/ct2/show/NCT01799941

 

Nuedexta Approval History (11-1-2010)

https://www.drugs.com/history/nuedexta.html

 

FDA Approves Nuedexta (10-29-2010)

https://www.drugs.com/newdrugs/avanir-pharmaceuticals-announces-fda-approval-nuedexta-2392.html

 

FDA Approval Letter (10-29-2010)

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021879s000ltr.pdf

FDA Approval Package (10-29-2010)

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=021879

 

Center for Drug Evaluation and Research 021879 (9-25-2010)

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021879Orig1s000MedR.pdf