Sunovion Pharmaceuticals Inc. to Present Data for COPD Portfolio and Pipeline at CHEST 2014

Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the company will present new data for products in its current portfolio and an investigational compound and device for the treatment of chronic obstructive pulmonary disease (COPD) at the 2014 American College of Chest Physicians annual meeting (CHEST 2014). The presentations will include one oral poster presentation, highlighting the efficacy and safety results from an investigational study of SUN-101 (glycopyrrolate inhalation solution) Phase 2, randomized, double-blind, placebo-controlled study for patients with moderate-to-severe COPD. CHEST 2014 will be held in Austin, Texas from October 25 through October 30, 2014.

“The clinical research program investigating SUN-101, delivered via the innovative, proprietary eFlow® nebulizer system, is an example of Sunovion’s commitment to COPD research and demonstrates the value of nebulization to deliver medications for patients with moderate-to-severe COPD,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion. “These data, along with others in our Phase 2 program, show that SUN-101 may be a potential treatment option for patients with moderate-to-severe COPD, and build on our long-standing heritage in COPD research, so we are excited to share them with the COPD medical community.”

SUN-101 is a long-acting muscarinic antagonist (LAMA) bronchodilator in development for the treatment of COPD that will be delivered via the eFlow® nebulizer system. The investigational eFlow® nebulizer system, manufactured by PARI, is fast, light, portable and runs silently. It reduces the time for administration, allowing patients to receive medication in approximately two minutes versus the standard jet nebulizer which takes up to 10 minutes. There are currently no nebulized LAMAs available on the market.

Additionally, Sunovion will present two posters reporting retrospective database analyses of a comparison of disease related healthcare resource utilization (HRU) and costs as well as incidence of exacerbations in COPD patients receiving nebulized long-acting beta2-agonists (LABAs), including Brovana® (arformoterol tartrate) Inhalation Solution.

BROVANA is a twice-daily nebulized LABA that treats bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema.

Further details about the oral poster presentation and posters presented by Sunovion at CHEST 2014 are available below.

SUN-101 Investigational Data Presented at CHEST 2014:

  • A Randomized, Double-Blind, Placebo-Controlled Study of SUN-101 (Glycopyrrolate Inhalation Solution) in Subjects with Moderate-to-Severe COPD – Monday, October 27, 2014, 1:30 PM-2:30 PM

BROVANA Health Economics and Outcomes Research (HEOR) Data Presented at CHEST:

  • Comparison of Disease Related Healthcare Resource Utilization (HRU) and Costs in Chronic Obstructive Pulmonary Disease (COPD) Patients Receiving Nebulized Long-Acting Beta2-Agonists (LABAs) – Wednesday, October 29, 2014, 1:30 PM-2:30 PM
  • Incidence of Exacerbations Among Chronic Obstructive Pulmonary Disease (COPD) Patients Receiving Nebulized Long-Acting Beta2-Agonists (LABAs) – Wednesday, October 29, 2014, 1:30 PM-2:30 PM

About Brovana® (arformoterol tartrate) Inhalation Solution

Brovana® (arformoterol tartrate) Inhalation Solution is indicated for the long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. BROVANA is for use by nebulization only.

Important Safety Information for BROVANA®

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including arformoterol, the active ingredient in BROVANA (see WARNINGS). The safety and efficacy of BROVANA in patients with asthma have not been established. All LABA, including BROVANA, are contraindicated in patients with asthma without use of a long-term asthma control medication (see CONTRAINDICATIONS).

BROVANA is not indicated for the treatment of acute episodes of bronchospasm, i.e., rescue therapy, and does not replace fast-acting rescue inhalers. BROVANA should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition.

BROVANA should not be used in conjunction with other inhaled, long-acting beta2-agonists. BROVANA should not be used with other medications containing long-acting beta2-agonists. Patients who have been taking inhaled short-acting beta2-agonists on a regular basis should be instructed to discontinue their regular use and to use them only for symptomatic relief for acute respiratory symptoms.

All LABA, including BROVANA, are contraindicated in patients with asthma without use of a long-term asthma control medication.

As with other inhaled beta2-agonists, BROVANA can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, BROVANA should be discontinued immediately and alternative therapy instituted.

BROVANA, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms.

BROVANA should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines.

BROVANA, as with other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents.

Overall efficacy of BROVANA was maintained throughout the 12-week trial duration. Some tolerance to the bronchodilator effect of BROVANA was observed after 6 weeks of dosing (at the end of the dosing interval), although the FEV1 improvement remained statistically significant. This was not accompanied by other clinical manifestations of tolerance.

The five most common adverse events reported with frequency ≥2% in patients taking BROVANA, and occurring more frequently than in patients taking placebo, were pain (8% vs 5%), chest pain (7% vs 6%), back pain (6% vs 2%), diarrhea (6% vs 4%), and sinusitis (5% vs 4%).For more information, please see the full Prescribing Information and Medication Guide for BROVANA.

For additional information, please see the full Prescribing Information and Medication Guide for BROVANA (arformoterol tartrate) Inhalation Solution.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About SUN-101

SUN-101, an inhalation solution of a long-acting muscarinic antagonist (LAMA) bronchodilator, glycopyrrolate, delivered by the innovative, proprietary eFlow® nebulizer system, is currently in development by Sunovion Respiratory Development Inc., a wholly-owned subsidiary of Sunovion Pharmaceuticals, Inc., for the treatment of patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD). Neither SUN-101 nor the eFlow® nebulizer system have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of COPD.

About the eFlow® Nebulizer System

The innovative, proprietary eFlow® nebulizer system, manufactured by PARI, is fast, light, portable, and runs silently. It reduces the time for administration, allowing patients to receive medication in approximately two minutes versus the standard jet nebulizer which takes up to 10 minutes. The eFlow® nebulizer system has not been approved by the U.S. Food and Drug Administration (FDA).

About Sunovion Pharmaceuticals Inc. (Sunovion)

Sunovion is a leading pharmaceutical company dedicated to discovering, developing and commercializing therapeutic products that advance the science of medicine in the Psychiatry & Neurology and Respiratory disease areas. Sunovion’s drug development program, together with its corporate development and licensing efforts, has yielded a portfolio of pharmaceutical products including Aptiom® (eslicarbazepine acetate), Latuda® (lurasidone HCl) tablets, Lunesta® (eszopiclone) tablets, Xopenex HFA® (levalbuterol tartrate) inhalation aerosol, Brovana® (arformoterol tartrate) inhalation solution, Omnaris® (ciclesonide) nasal spray, Zetonna® (ciclesonide) nasal aerosol and Alvesco®(ciclesonide) inhalation aerosol.

Sunovion, an indirect, wholly-owned U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is headquartered in Marlborough, Mass. More information about Sunovion Pharmaceuticals Inc. is available at www.sunovion.com.

About Sumitomo Dainippon Pharma Co., Ltd.

Sumitomo Dainippon Pharma is a top-ten listed pharmaceutical company in Japan. Sumitomo Dainippon Pharma aims to produce innovative pharmaceutical products in the Psychiatry & Neurology area and the Oncology area, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has about 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at www.ds-pharma.com

LATUDA is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd. LUNESTA, XOPENEX, XOPENEX HFA, and BROVANA are registered trademarks of Sunovion Pharmaceuticals Inc. OMNARIS and ALVESCO are registered trademarks of Takeda GmbH, used under license.

APTIOM is under license from BIAL.

Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd.©

2014 Sunovion Pharmaceuticals Inc.

For a copy of this release, visit Sunovion’s web site at www.sunovion.com

Contacts:

Sunovion Pharmaceuticals, Inc.
Patrick Gaffey, 508-357-7740
Sr. Director, Corporate Communications
patrick.gaffey@sunovion.com

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