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Santarus And VeroScience Announce CYCLOSET (bromocriptine Mesylate) Data Presentations At The American Diabetes Association Meeting

Santarus, Inc. (NASDAQ: SNTS) and VeroScience, LLC today announced that clinical data on CYCLOSET ® (bromocriptine mesylate) will be featured in two poster presentations at the 73 rd Scientific Sessions of the American Diabetes Association being held at McCormick Place in Chicago, Ill. from June 21 – 25, 2013.

The posters will be displayed in the Poster Hall on Saturday, Sunday and Monday, June 22-24 with presentations and author availability scheduled as follows:
  • The Anti-Diabetes Efficacy of Bromocriptine-QR in Type 2 Diabetes Mellitus (T2DM) Subjects is Enhanced Among Those with Elevated Blood Pressure and Plasma Triglyceride Levels
    • Poster Presentation1172-P in category 01-D Clinical Therapeutics/New Technology – Oral Agents, authors available Sunday, June 23, 12:00 p.m. - 2:00 p.m. CDT.
  • Bromocriptine-QR Attenuates the Progression to Both Cardiovascular (CV) Averse Events and Worsening Hyperglycemia in Type 2 Diabetes Mellitus (T2DM) Subjects in Good Glycemic Control
    • Poster Presentation - 1193-P in category 01-F Clinical Therapeutics/New Technology – Pharmacologic Treatment of Complications, authors available Saturday, June 22, 11:30 a.m. - 1:30 p.m. CDT.

CYCLOSET Indications and Usage
  • CYCLOSET is a prescription medication that contains bromocriptine mesylate and is combined with diet and exercise to help control blood sugar in adults with type 2 diabetes mellitus.
  • CYCLOSET is not for people with type 1 diabetes.
  • CYCLOSET is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).

Dosage and Administration

CYCLOSET tablets should be taken once a day within two hours of waking and with food.

Important Safety Information

Warnings and Precautions
  • Do not take CYCLOSET if you are allergic to bromocriptine, other ergot-related drugs, or any of the other ingredients in CYCLOSET.
  • Do not take CYCLOSET if you have been diagnosed with a syncopal migraine.
  • Women who are breast-feeding their children should not take CYCLOSET.
  • CYCLOSET is not for people with type 1 diabetes.
  • CYCLOSET is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).

Adverse Reactions
  • The most common side effects of CYCLOSET include nausea, fatigue, dizziness, vomiting, and headache.
  • CYCLOSET has been associated with low blood pressure (hypotension) with or without symptoms such as dizziness, nausea, and/or excessive sweating. This may occur more frequently during initial therapy or with an increase in dose at any time during your treatment. A sudden drop in blood pressure can result from changes in body position, such as standing up from a seated position or getting out of bed too quickly.
  • CYCLOSET has been associated with increased drowsiness and very rare episodes of sudden sleep onset during daily activities without awareness or warning signs. Exercise caution while driving or operating heavy machinery until you know how CYCLOSET affects your level of alertness.
  • CYCLOSET alone does not usually cause low blood sugar (hypoglycemia). However, low blood sugar may occur when CYCLOSET is used in combination with certain other diabetes medications such as a sulfonylurea or insulin.
    • Signs and symptoms of low blood sugar (hypoglycemia) may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heart beat, sweating, feeling jittery (nervousness or nervous shaking).

Drug Interactions
  • Tell your doctor about all of the medicines you take, both prescription and non-prescription drugs, including vitamins and herbal supplements. CYCLOSET may interact with other medicines you are currently taking. Your doctor may order laboratory testing to monitor these interactions.
  • Separate taking CYCLOSET and certain migraine medications (ergot derivatives) by at least 6 hours.

CYCLOSET is available by prescription only. For additional information, talk to your doctor and see Full Prescribing Information including Patient Labeling, which is available by clicking here Full Prescribing Information or by contacting Santarus at (888) 778-0887.

About VeroScience

VeroScience is a privately held biotechnology and healthcare product development company with main offices and laboratories in Tiverton, R.I. VeroScience holds the New Drug Application and related technology for CYCLOSET and has a large patent portfolio that supports its preclinical and clinical development programs and product pipeline in the areas of metabolism, immunology and oncology. VeroScience leverages its intellectual property and products in out-licensing and collaborative arrangements with appropriate industry partners.

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