FDA Brief, Week of September 14, 2015 – Drug and Device Digest

MIND1U.S. FDA Accepts First Digital Medicine New Drug Application for Otsuka and Proteus Digital Health

  • The first Digital Medicine, a drug/device product, combines Otsuka’s ABILIFY® (aripiprazole) for serious mental illness, embedded with the Proteus® ingestible sensor in a single tablet to digitally record ingestion and, with patient consent, share information with their healthcare professionals and caregivers
  • Otsuka and Proteus are pursuing a regulatory filing for a drug-device combination across multiple divisions of the FDA to support the unique system
  • First opportunity to demonstrate the potential of Digital Medicines to provide an objective measure of medication adherence and physiologic response

This is the first time an FDA-approved medication (ABILIFY) has been combined and submitted for approval with a sensor within the medication tablet (the Proteus ingestible sensor) to measure actual medication-taking patterns and physiologic response. This objective information is communicated to the patient – and with the consent of the patient – to the patient’s physician and/or caregiver. Digital Medicines may enable improved patient medication adherence and better informed physician decision-making to tailor treatment to the patient’s needs.

Digital Health inclDigital healthudes mobile medical Apps (MMAs), Health IT , wearable devices. FDA’s evolving regulations at this site:


Quick Recap Federal Food, Drug, and Cosmetic Act (FD&C Act): Drug, Not a Drug, or More?



– Is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease

– Is intended to affect the structure or any function of the body of man or other animals

Medical Device:

– Is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease

– Is intended to affect the structure or any function of the body of man or other animals

– Does not achieve its primary intended purposes through chemical action within or on the body of man or other animals

– Is not dependent upon being metabolized for the achievement of any of its primary intended purposes

Cosmetic is intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body. . . for cleansing, beautifying, promoting attractiveness, or altering the appearance.

Dietary supplement (as defined in the Dietary Supplement Health and Education Act (DSHEA) of 1994) is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet.

Biological product, as defined in section 351(i) of the Public Health Service Act, is a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.

Combination Product:

  • Two or more regulated products (drug/device, biologic/device, drug/biologic, drug/device/biologic) impregnated with a drug or biologic.
  • Two or more separate products packaged together in a single package
  • Packaged separately but both are required to achieve the intended use, indication, or effect
  • Packaged separately that is for use only with another individually specified investigational drug, device, or biological product


FDA approved

Vraylar  (Cariprazine, Forest Laboratories LLC of Jersey City, NJ)


  •  Treatment of schizophrenia
  • Acute treatment of manic or mixed episodes associated with bipolar I disorder

Mechanism of Action:

Could be mediated through a combination of partial agonist activity at central dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors.


Schizphrenia : Three 6-week, randomized, double-blind, placebo-controlled trials

  • Primary endpoint: Positive and Negative Syndrome Scale (PANSS)
  • Secondary endpoint  : Clinical Global Impressions-Severity (CGI-S)
  • All studies  showed superiority to placebo on the PANSS total score and the CGI-S.

Bipolar Disorder : Three, 3-week placebo-controlled trials

  • Primary endpoint : Young Mania Rating Scale (YMRS)
  • Secondary endpoint : CGI-S:
  • All studies showeed superiority to placebo in  YMRS total score and the CGI-S.


Warnings and Precautions: Increased Mortality in Elderly Patients, Stroke, in Elderly Patients, Neuroleptic Malignant Syndrome, Tardive Dyskinesia.

Other events :

Schizophrenia :  Extrapyramidal symptoms, such as tremor, slurred speech, and involuntary muscle movements.

Bipolar disorder : Extrapyramidal symptoms, the urge to move (akathisia), indigestion (dyspepsia), vomiting, drowsiness (somnolence) and restlessness.

The sponsor is requited to conduct a Pediatric program.

SureFire Precision System (Sure Fire Medical, Westminster, CO)


Reg Pathway : 510K

Use : System for delivering drugs directly into tumors. It’s designed to focus chemotherapy within the tumor itself, avoiding unnecessary damage to healthy tissue around the tumor. So far it’s only intended for attacking liver cancer.

Clinical Evaluation : , Clinical study on primary liver cancer, Surefire technology enabled increased uptake of particles by an average of 68 percent, and up to 90 percent, compared to use of conventional end-hole catheters.

Source: Surefire Medical…

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