U.S Food and Drug Administration Approves Updated Label for Otsuka’s BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) to Detect Presence of Helicobacter Pylori (H. pylori) Infection

ROCKVILLE, M.D. AND PRINCETON, N.J., June 4, 2013 Otsuka America Pharmaceutical, Inc. (OAPI) announced today that BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) may be administered to patients who are taking proton-pump inhibitors (PPIs). Patients who took PPIs within the last 2 weeks can still be tested according to the updated BreathTek UBT Kit labeling, but the test result needs to be interpreted with caution. It is still recommended that patients should not have taken antimicrobials, PPIs and bismuth preparations within 2 weeks prior to testing with BreathTek UBT Kit. If PPIs are used within 2 weeks, a positive result could be considered positive and be acted upon.  A negative result may occur and the test should be repeated 2 weeks after discontinuing PPI use. The label change is supported by published clinical studies that evaluated the effects of PPI use on the UBT method in patients taking the test. With this label update, patients on a PPI may be tested using the BreathTek UBT Kit for initial diagnosis of H. pylori infection without stopping the use of a PPI, resulting in an opportunity of earlier detection and start of eradication therapy for H. pylori infection.1  H. pylori remains one of the most prevalent, worldwide chronic infections, and is estimated to infect 30-40 percent of the U.S. population.2 This bacterium infects the stomach leading to the development of peptic ulcer disease, gastric malignancy and dyspeptic symptoms.2 H. pylori can penetrate the stomach’s protective mucous making the lining of the stomach more susceptible to the damaging effects of gastric acids, which can lead to sores or ulcers in the stomach or small intestine.3 These bacteria also have been shown to weaken the stomach’s defensive mechanisms, produce local inflammation and stimulate the stomach to produce more acid.4 As a result, H. pylori is the cause of  more than 90 percent of duodenal ulcers and as many as 80 percent of gastric ulcers.3 Due to this correlation with peptic ulcers, many patients with an H. pylori infection use PPI therapy to reduce the amount of stomach acid made by glands in the lining of the stomach.5

About BreathTek® UBT for H. pylori Kit 

BreathTek UBT Kit is a non-invasive test that measures the ratio of 13CO2 to 12CO2 in patients’ breath samples to detect the presence of urease associated with H. pylori as an aid to diagnose infection, as well as confirm that H. pylori infection has been eradicated after antibiotic therapy. Administered in four simple steps, the BreathTek UBT Kit provides a convenient alternative to difficult or invasive tests for H. pylori, which require blood, stool samples or endoscopy. BreathTek UBT Kit has demonstrated high sensitivity (95.5%) and specificity (96.0%) to confirm the eradication of H. pylori following antibiotic treatment in adult patients. Confirming eradication is highly recommended due to the evidence that suggests eradication therapy can fail in one out of every four patients treated with antibiotics for H. pylori infections. Both the American College of Gastroenterology (ACG) and the American Gastroenterological Association (AGA) guidelines recommend the non-invasive UBT method as an appropriate choice for the initial diagnosis and confirmation of H. pylori eradication by antibiotic treatments.

IMPORTANT SAFETY INFORMATION

INTENDED USE:

The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adult patients. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples, in clinical laboratories or point-of-care settings. The BreathTek UBT Kit is for administration by a health care professional, as prescribed by a physician.

WARNINGS AND PRECAUTIONS:

  1. For in vitro diagnostic use only. The Pranactin®-Citric solution is taken orally as part of the diagnostic procedure.
  2. Phenylketonurics: Contains Phenylalanine (one of the protein components of Aspartame), 84 mg per dosage unit. (For reference, 12 ounces of typical diet cola soft drinks contain approximately 80 mg of Phenylalanine.)
  3. Blood glucose: Use with caution in diabetic patients. Pranactin-Citric contains Aspartame.
  4. A negative result does not rule out the possibility of H. pylori infection. False negative results do occur with this procedure. If clinical signs are suggestive of H. pylori infection, retest with a new sample or an alternate methods.
  5. False negative test results may be caused by:
    1. Ingestion of proton pump inhibitors (PPIs) within 2 weeks prior to performing the BreathTek UBT. If a negative result is obtained from a patient ingesting a PPI within 2 weeks prior to the BreathTek UBT, it may be a false-negative result and the test should be repeated 2 weeks after discontinuing the PPI treatment. A positive result for a patient on a PPI can be considered positive and be acted upon.
    2. Ingestion of antimicrobials or bismuth preparations within 2 weeks prior to performing the BreathTek UBT
    3. Premature POST-DOSE breath collection time for a patient with a marginally positive BreathTek UBT result
    4. Post-treatment assessment with the BreathTek UBT less than 4 weeks after completion of treatment for the eradication of H. pylori.
  1. False positive test results may be caused by:
    1. Urease associated with other gastric spiral organisms observed in humans such as Helicobacter heilmannii
    2. Achlorhydria.
  1. If particulate matter is visible in the reconstituted Pranactin-Citric solution after thorough mixing, the solution should not be used.
  2. Hypersensitivity: Patients who are hypersensitive to mannitol, citric acid or Aspartame should avoid taking the drug solution as this drug solution contains these ingredients.
  3. Risk of Aspiration: Use with caution in patients with difficulty swallowing or who may be at high risk of aspiration due to medical or physical conditions.
  4. Pregnancy: No information is available on use of the Pranactin-Citric solution during pregnancy.


POSTMARKETING EXPERIENCE:

During post-approval use of the BreathTek UBT, the following adverse events have been identified: anaphylactic reaction, hypersensitivity, rash, burning sensation in the stomach, tingling in the skin, vomiting and diarrhea. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to establish a causal relationship to drug exposure.


LIMITATIONS: 

  1. The BreathTek UBT should not be used until 4 weeks or more after the end of treatment for the eradication of H. pylori as earlier post-treatment assessment may give false negative results.
  2. The specimen integrity of breath samples and reference gases stored in breath bags under ambient conditions has not been determined beyond 7 days.
  3. A correlation between the number of H. pylori organisms in the stomach and the BreathTek UBT result has not been established.

PATIENT PREPARATION:

  1. Remind the patient that Pranactin-Citric contains phenylalanine (one of the protein components of Aspartame). Phenylketonurics restrict dietary phenylalanine.
  2. The patient should have fasted at least 1 hour before administering the BreathTek UBT.
  3. The patient should not have taken antimicrobials, proton pump inhibitors, or bismuth preparations within 2 weeks prior to administering the BreathTek UBT. If PPIs are used within 2 weeks of BreathTek UBT testing, false negative test results may occur, and the test should be repeated 2 weeks after discontinuation of PPI treatment. A positive result for a patient on PPI could be considered positive and be acted upon.
  4. For administration by a healthcare professional only. Do not provide this kit to the patient for self-administration.

About Otsuka America Pharmaceutical, Inc. (OAPI)

Otsuka America Pharmaceutical, Inc. (OAPI) is an innovative, fast-growing healthcare company that commercializes Otsuka-discovered and in-licensed products in the U.S. With a strong focus on neuroscience, oncology, cardio-renal and medical device, OAPI is dedicated to improving patient health and the quality of human life. OAPI is part of the Otsuka Group companies. For more information, visit http://www.otsuka-us.com
U.S.
Rose Weldon 
Otsuka America Pharmaceutical, Inc.
+1 609 524 6879+1 215 801 7644 (cell)
rose.weldon@otsuka-us.com
JAPAN /ASIA
Jeffrey Gilbert
Otsuka Pharmaceutical Co., Ltd.
+81 3 6361 7379+81 80 2066 7289 (cell)
gilbert.jeffrey@otsuka.jp
EUROPE
Alison Ross
Otsuka Pharmaceutical Europe, Ltd.
+44 7768 337 128 (cell)
ARoss@Otsuka-Europe.com
INVESTOR INQUIRIES
Takuma Kimura
Otsuka Holdings Co., Ltd.
+81 3 6361 7411+81 90 9010 7194
kimura@otsuka.jp

References:

  1. Otsuka Internal Analysis On File
  2. Chey, William D., and Benjamin CY Wong. "American College of Gastroenterology Guideline on the Management of Helicobacter Pylori Infection." American Journal of Gastroenterology (2007): 1808-825.
  3. "H. Pylori Fact Sheet." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, n.d. Web. 23 May 2013. http://www.cdc.gov/ulcer/keytocure.htm.
  4. Mobley, Harry L. T., George L. Mendz, and Stuart L. Hazell. Helicobacter Pylori: Physiology and Genetics. Washington, DC: ASM, 2001.
  5. "Proton Pump Inhibitors: MedlinePlus Medical Encyclopedia." U.S National Library of Medicine. U.S. National Library of Medicine, n.d. Web. 23 May 2013. http://www.nlm.nih.gov/medlineplus/ency/patientinstructions/000381.htm.
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