Cycloset is recommended for dual therapy for patients with entry HbA1c ≥ 7.5%
SAN DIEGO & TIVERTON, R.I. –(BUSINESS WIRE)– Santarus, Inc. (NASDAQ: SNTS) and VeroScience, LLC today announced the inclusion of Cycloset® (bromocriptine mesylate) as a therapy for patients with type 2 diabetes in a new comprehensive diabetes management algorithm published by the American Association of Clinical Endocrinologists (AACE). The AACE created the algorithm to guide primary care physicians, endocrinologists and other health care professionals in the treatment of prediabetes and type 2 diabetes patients.
- For patients with entry hemoglobin A1c (HbA1c) ≥ 7.5%, the AACE algorithm recommends dual therapy to include Cycloset as one option in combination with metformin or another first-line agent.
- Cycloset is also listed as a treatment option for patients that need triple therapy and for those patients without symptoms that present with an HbA1c > 9.0%.
In support of the new treatment algorithm, AACE provides a matrix profiling attributes of several anti-diabetes medications. The matrix highlights the demonstrated cardiovascular safety profile of Cycloset and provides a “neutral” rating for Cycloset for hypoglycemia, weight gain, renal function, congestive heart failure and bone loss, and a “moderate” rating for GI effects.
“Choosing appropriate therapies for patients with type 2 diabetes is challenging and must be individualized based on a number of patient risk factors. Cycloset is an interesting and useful therapy, both because of its beneficial impact on HbA1c and the fact that in clinical testing it was not associated with increased risk for adverse cardiovascular events,”* according to Alan J. Garber, M.D., Ph.D., FACE, professor of medicine, biochemistry and molecular biology, and molecular and cellular biology in the Division of Diabetes , Endocrinology and Metabolism at the Baylor College of Medicine in Houston, Texas , and chair of the algorithm task force and president of AACE.
“We believe that the addition of Cycloset to the AACE comprehensive diabetes management algorithm will increase awareness and exposure for Cycloset with endocrinologists and other physicians who as of yet may not prescribe it for their adult patients with type 2 diabetes,” said Thomas J. Joyce, vice president, marketing and national accounts of Santarus .
Important Safety Information
Cycloset is a dopamine receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Contraindications
Cycloset is contraindicated in:
- Patients with known hypersensitivity to bromocriptine, ergot-related drugs, or any of the excipients in Cycloset.
- Patients with syncopal migraine. Bromocriptine increases the likelihood of a hypotensive episode among patients with syncopal migraine. Loss of consciousness during a migraine may reflect dopamine receptor hypersensitivity. Cycloset is a dopamine receptor agonist, and may, therefore, potentiate the risk for syncope in these patients.
- Women who are nursing their children. Cycloset may inhibit lactation. There are postmarketing reports of stroke in this patient population although causality has not been proven.
Warnings and Precautions
- Hypotension: Can cause orthostatic hypotension and syncope, particularly upon initiation or dose escalation. Use caution in patients taking anti-hypertensive medications. Assess orthostatic vital signs prior to initiation of Cycloset and periodically thereafter. Advise patients during early treatment to avoid situations that could lead to injury if syncope was to occur.
- Psychosis: May exacerbate psychotic disorders or reduce the effectiveness of drugs that treat psychosis. Use in patients with severe psychotic disorders is not recommended.
- Somnolence: May cause somnolence. Advise patients not to operate heavy machinery if symptoms of somnolence occur.
- Interaction with dopamine antagonists: Concomitant use with dopamine antagonists such as neuroleptic agents may diminish the effectiveness of both drugs. Concomitant use is not recommended.
- Other dopamine receptor agonists: Effectiveness and safety are unknown in patients already taking dopamine receptor agonists for other indications. Concomitant use is not recommended.
- Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Cycloset or any other anti-diabetes drug. Cycloset does not increase the risk of macrovascular events.
Adverse Reactions
In controlled clinical trials, adverse reactions reported in ≥5% of patients treated with Cycloset and reported more commonly than in patients treated with placebo, included nausea, fatigue, dizziness, vomiting, and headache.
Postmarketing reports with higher doses of bromocriptine used for other indications include psychotic disorders, hallucinations, and fibrotic complications.
Drug Interactions
- May increase the unbound fraction of highly protein-bound therapies, altering their effectiveness and safety profiles.
- May increase ergot-related side effects or reduce ergot effectiveness for migraines if co-administered within 6 hours of ergot-related drugs.
- Extensively metabolized by CYP3A4. Use caution when co-administering strong inhibitors, inducers, or substrates for CYP3A4.
The Important Safety Information does not include all the information needed to use Cycloset safely and effectively. See Full Prescribing Information for Cycloset for additional information, available at www.cycloset.com or by contacting Santarus at 888-778-0887.
*Findings from a 52-week, 74-center, randomized placebo-controlled trial to evaluate the safety of Cycloset. 3,070 patients were randomized 2:1 to add either Cycloset or placebo, respectively, to their current anti-diabetes regimen, which could consist of diet alone or no more than two agents; two oral anti-diabetes (OAD) medications or insulin + one OAD. Inclusion criteria: age 30-80, BMI < 43 kg/m2, diagnosis of type 2 diabetes of > 6 months with an A1c ≤10.0% with no lower A1c boundary. Patients with a history of cardiovascular disease and congestive heart failure were included in the trial.
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.
About Santarus
Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company’s current commercial efforts are focused on five products. UCERIS™(budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis and ZEGERID®(omeprazole/sodium bicarbonate) for the treatment of certain upper gastrointestinal disorders are promoted to gastroenterologists. GLUMETZA®(metformin hydrochloride extended release tablets) and Cycloset®(bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes, and FENOGLIDE®(fenofibrate) tablets, which is indicated as an adjunct to diet to reduce high cholesterol, are promoted to endocrinologists and other physicians who treat patients with type 2 diabetes. Full prescribing and safety information for Santarus’ products is available at www.santarus.com.
Santarus’ product development pipeline includes the investigational drug RUCONEST® (recombinant human C1 esterase inhibitor). A biologics license application (BLA) for RUCONEST was submitted to the FDA in April 2013 for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE). Santarus is also developing rifamycin SV MMX®, which is in Phase III clinical testing for treatment of travelers’ diarrhea. In addition, the company has completed a Phase I clinical program with SAN-300, an investigational monoclonal antibody. More information about Santarus is available at www.santarus.com.
Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans or objectives will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus’ business, including, without limitation: risks associated with the collaboration relating to Cycloset, including the potential for termination of the collaboration; competition from other products; unexpected adverse side effects or inadequate therapeutic efficacy of Santarus’ products and product candidates; the scope and validity of patent protection for Santarus’ products and product candidates; and other difficulties or delays relating to the development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus’ products and product candidates; and other risks detailed in Santarus’ prior press releases as well as in prior public periodic filings with the Securities and Exchange Commission .
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Santarus ®, FENOGLIDE®, UCERIS™ and ZEGERID®are trademarks of Santarus, Inc. GLUMETZA®is a trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. Cycloset®is a trademark of VeroScience LLC . MMX®is a trademark of Cosmo Technologies Limited . RUCONEST®is a trademark of Pharming Group N.V.
Santarus, Inc.
Martha L. Hough, 858-314-5824
VP Finance & Investor Relations
or
Debra P. Crawford, 858-314-5708
Chief Financial Officer
or
Westwicke Partners, LLC for Santarus, Inc.
Stefan Loren, Ph.D., 858-356-5930
sloren@westwicke.com
or
Robert Uhl, 858-356-5932
robert.uhl@westwicke.com
or
VeroScience, LLC
Anthony H. Cincotta, Ph.D., 401-816-0525
President and Chief Scientific Officer
