FDA BRIEF: Week of May 23, 2016

FDA approved

 

PROBUPHINE (Buprenorphine) Implant

Titan Pharmaceuticals Inc. San Francicso, CA and Braeburn Pharmaceuticals, Princeton, NJ, USA

INDICATION: Maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine-containing product

UNMET NEED

  • Opioid abuse and addiction have taken a devastating toll
  • Need for new innovative treatment options to regain control
  • Implant a better option that currently available pill or film
  • Medication-assisted treatment (MAT) options  important component of the FDA’s opioid action plan
  • One of three top priorities for the DHHS’  Initiative to reduce prescription opioid and heroin related overdose, death and dependence.

REG PATHWAY: NDA

MECHANISM OF ACTION: Buprenorphine is a partial agonist at the muopioid receptor and an antagonist at the kappa-opioid receptor. Implant provides constant, low-level dose for six months

EFFICACY:

  • Single randomized double-blind, double-dummy study (n=176), subjects meeting criteria for opioid dependence  and  clinically stable on  sublingual buprenorphine, PROBUPHINE vs sublingual buprenorphine
  • Endpoint: Detect opioid use, over the 6-month treatment period, measured by urine screening and self-reporting of illicit opioid use
  • 63% PROBUPHINE vs 64% sublingual  buprenorphine

SAFETY:

  • Boxed warning:  Risk of implant migration, protrusion, expulsion and nerve damage
  • Common side effects: Implant-site pain, itching, and redness, headache, depression, constipation, nausea, vomiting, back pain, toothache and oropharyngeal pain

LABEL


AXUMIN  (fluciclovine F 18) injection for PET imaging 

Blue Earth Diagnostics, Ltd., Oxford, UK

INDICATION:  For PET in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

UNMET NEED:

  • Prostate cancer second leading cause of death from cancer
  • In suspected cancer recurrence cases, accurate staging important in improving management and outcomes.
  • Need for imaging tests to determine location of recurrent cancer when PSA is at very low levels

REG PATHWAY: NDA

MECHANISM OF ACTION: Fluciclovine F 18, synthetic amino acid transported across mammalian cell membranes by transporters  LAT-1 and ASCT2, which are upregulated in prostate cancer cells. Fluciclovine F 18 taken up to a greater extent in prostate cancer cells vs. surrounding normal tissues.

EFFICACY:

  • 2 studies in men with suspected recurrence of prostate cancer based on rising PSA levels following radical prostatectomy and/or radiotherapy
  • Study 1 (n=105): Comparison of AXUMIN scans vs  prostate biopsy. Consistent with on-site reads
  • Study 2 : 96 AXUMIN vs  C11 choline scan. Agreement between readings
  • Clinical correlation, which may include histopathological evaluation of the suspected recurrence site, is recommended.

SAFETY

  • Radioactive drug; should be handled with appropriate safety measures
  • Commonly reported adverse reactions: Injection site pain, redness, and a metallic taste in the mouth

LABEL


 

EPI PROCOLON

Epigenomics AG, Berlin, GERMANY 

INDICATION FOR USE: Qualitative in vitro diagnostic test for the detection of methylated Septin 9 DNA  associated with the occurrence of colorectal cancer (CRC)

REG PATHWAY: PMA, Priority Review because first of a kind device that uses breakthrough technology. Device Code: PHP

  •  Molecular and Clinical Genetics Advuisory Panel voted to approve;  indicated in a second-line setting, post-approval study to evaluate the programmatic performance

DEVICE DESCRIPTION:

  • In vitro polymerase chain reaction (PCR) assay for the qualitative detection of methylated Septin 9 DNA isolated from  patient plasma
  • 3 components: Epi proColon Plasma Quick Kit, Epi proColon Sensitive PCR Kit, Epi proColon Control Kit
  • Plasma Quick Kit: Extraction, purification and conversion of DNA from plasma.
  • Sensitive PCR Kit: Amplify and detect the methylated Septin 9 (mSEPT9) target region and a control region in the β-actin gene (ACTB) in one PCR reaction
  • Colon Control Kit: Test validity of each run

EFFECTIVENESS:

  • Study 1: 68.2% sensitivity, 80.0% specificity vs colonoscopy results
  • Study 2: 73.3% sensitivity, 81.5% specificity vs. colonoscopy results
  • Study 3:  Based on  recommendations from advisory committee – to evaluate adherence in a study population with a history of non-compliance.  99.5% of the study population underwent screening with Epi proColon
  • Patient perspective assessment: Epi proColon provides an option for adults  unable or unwilling to undergo routine CRC screening tests

SAFETY:

  • Erroneous device results could delay detection of CRC
  • False positive results could lead to an increased number of colonoscopies

LABEL

 

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