Study Findings Presented at the 2014 American College of Chest Physicians Annual Meeting (CHEST 2014) in Austin
MARLBOROUGH, MA, USA I October 27, 2014 I Sunovion Pharmaceuticals Inc. (Sunovion) today announced dose ranging results from a Phase 2, randomized, double-blind, placebo-controlled, parallel group study of SUN-101 (glycopyrrolate inhalation solution) delivered via the innovative, proprietary eFlow® nebulizer system twice a day in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). All four doses (12.5 mcg, 25 mcg, 50 mcg, and 100 mcg) studied produced statistically and clinically significant changes in forced expiratory volume in one second (trough FEV1) in bronchodilation, which persisted throughout the 24-hour dosing interval to inform dose selection. Data were presented at the 2014 American College of Chest Physicians annual meeting (CHEST 2014) in Austin.
“While the efficacy and safety of SUN-101 have yet to be established, the data from this dose-ranging study illustrates that SUN-101 may be a potential treatment option for patients with moderate-to-severe COPD,” said lead investigator Edward Kerwin, M.D., Medical Director of the Clinical Research Institute in Southern Oregon. “It’s important to develop a nebulized long-acting muscarinic antagonist, which is not currently available, to ensure that patients have a variety of treatment options and can work with their healthcare provider to determine which treatments are most appropriate for them.”
The primary endpoint of the study was change from baseline in morning trough FEV1 after 28 days of treatment.
Results are as follows:
| |
|
|
|
|
|
|
|
|
| SUN-101 Doses |
|
|
|
FEV1 Improvements
(placebo adjusted LS Mean [95% CI] and p≤.005 vs placebo)
|
|
|
|
FEV1 AUC0-12 Changes in Baseline
(LS mean [95% CI] and p≤.005 vs placebo)
|
| 12.5 mcg |
|
|
|
117 (37, 197) mL |
|
|
|
136 (71, 201) mL |
| 25 mcg |
|
|
|
128 (48, 209) mL |
|
|
|
163 (98, 228) mL |
| 50 mcg |
|
|
|
146 (67, 226) mL |
|
|
|
105 (42, 169) mL |
| 100 mcg |
|
|
|
177 (99, 255) mL |
|
|
|
183 (120, 246) mL |
| |
|
|
|
|
|
|
|
|
The most commonly reported adverse events were COPD exacerbations and headache, reported by 3.2 percent and 2.8 percent of the population respectively.
“The SUN-101 clinical trial further supports nebulization as a potential treatment alternative to deliver medication for patients with moderate-to-severe COPD,” said Alistair Wheeler, M.D., Vice President of Clinical Research and Medical Affairs of Sunovion Pharmaceuticals Inc. “The continued development of SUN-101 affirms Sunovion’s pledge to helping COPD patients and healthcare providers and addressing the evolving needs of the COPD community by investigating potential additional treatment options.
SUN-101 is a long-acting muscarinic antagonist (LAMA) bronchodilator in development for the treatment of COPD that will be delivered via the innovative, propriety eFlow® nebulizer system. SUN-101 and the eFlow® device are currently being investigated as a treatment option for COPD and have not been approved by the U.S. Food and Drug Administration (FDA). Studies evaluating the efficacy and safety of SUN-101 delivered via the eFlow® nebulizer system for the treatment of COPD are ongoing.
About the SUN-101 Phase 2 Study
This randomized, double-blind, placebo-controlled parallel group study enrolled 282 study participants between the ages of 42 and 75 with COPD and a baseline ≥ 30 percent and ≤ 70 percent forced expiratory volume in one second (FEV1) and ≥ 10 pack-year smoking history. Study participants were randomized to receive one of four doses of SUN-101 (12.5 mcg, 25 mcg, 50 mcg, 100 mcg) or placebo BID for 28 days, and were evaluated for change from baseline in morning trough FEV1 after 28 days of treatment. All study participants receiving LABA or LAMA therapy had their treatment replaced with albuterol MDI as “rescue therapy.” Inhaled corticosteroids and roflumilast were continued throughout the study. The study was sponsored by Sunovion Respiratory Development Inc., a wholly-owned subsidiary of Sunovion Pharmaceuticals Inc.
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
LATUDAis a registered trademark of Sumitomo Dainippon Pharma Co., Ltd. LUNESTA, 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.
SOURCE: Sunovion Pharmaceuticals
Post Views: 42
Study Findings Presented at the 2014 American College of Chest Physicians Annual Meeting (CHEST 2014) in Austin
MARLBOROUGH, MA, USA I October 27, 2014 I Sunovion Pharmaceuticals Inc. (Sunovion) today announced dose ranging results from a Phase 2, randomized, double-blind, placebo-controlled, parallel group study of SUN-101 (glycopyrrolate inhalation solution) delivered via the innovative, proprietary eFlow® nebulizer system twice a day in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). All four doses (12.5 mcg, 25 mcg, 50 mcg, and 100 mcg) studied produced statistically and clinically significant changes in forced expiratory volume in one second (trough FEV1) in bronchodilation, which persisted throughout the 24-hour dosing interval to inform dose selection. Data were presented at the 2014 American College of Chest Physicians annual meeting (CHEST 2014) in Austin.
“While the efficacy and safety of SUN-101 have yet to be established, the data from this dose-ranging study illustrates that SUN-101 may be a potential treatment option for patients with moderate-to-severe COPD,” said lead investigator Edward Kerwin, M.D., Medical Director of the Clinical Research Institute in Southern Oregon. “It’s important to develop a nebulized long-acting muscarinic antagonist, which is not currently available, to ensure that patients have a variety of treatment options and can work with their healthcare provider to determine which treatments are most appropriate for them.”
The primary endpoint of the study was change from baseline in morning trough FEV1 after 28 days of treatment.
Results are as follows:
| |
|
|
|
|
|
|
|
|
| SUN-101 Doses |
|
|
|
FEV1 Improvements
(placebo adjusted LS Mean [95% CI] and p≤.005 vs placebo)
|
|
|
|
FEV1 AUC0-12 Changes in Baseline
(LS mean [95% CI] and p≤.005 vs placebo)
|
| 12.5 mcg |
|
|
|
117 (37, 197) mL |
|
|
|
136 (71, 201) mL |
| 25 mcg |
|
|
|
128 (48, 209) mL |
|
|
|
163 (98, 228) mL |
| 50 mcg |
|
|
|
146 (67, 226) mL |
|
|
|
105 (42, 169) mL |
| 100 mcg |
|
|
|
177 (99, 255) mL |
|
|
|
183 (120, 246) mL |
| |
|
|
|
|
|
|
|
|
The most commonly reported adverse events were COPD exacerbations and headache, reported by 3.2 percent and 2.8 percent of the population respectively.
“The SUN-101 clinical trial further supports nebulization as a potential treatment alternative to deliver medication for patients with moderate-to-severe COPD,” said Alistair Wheeler, M.D., Vice President of Clinical Research and Medical Affairs of Sunovion Pharmaceuticals Inc. “The continued development of SUN-101 affirms Sunovion’s pledge to helping COPD patients and healthcare providers and addressing the evolving needs of the COPD community by investigating potential additional treatment options.
SUN-101 is a long-acting muscarinic antagonist (LAMA) bronchodilator in development for the treatment of COPD that will be delivered via the innovative, propriety eFlow® nebulizer system. SUN-101 and the eFlow® device are currently being investigated as a treatment option for COPD and have not been approved by the U.S. Food and Drug Administration (FDA). Studies evaluating the efficacy and safety of SUN-101 delivered via the eFlow® nebulizer system for the treatment of COPD are ongoing.
About the SUN-101 Phase 2 Study
This randomized, double-blind, placebo-controlled parallel group study enrolled 282 study participants between the ages of 42 and 75 with COPD and a baseline ≥ 30 percent and ≤ 70 percent forced expiratory volume in one second (FEV1) and ≥ 10 pack-year smoking history. Study participants were randomized to receive one of four doses of SUN-101 (12.5 mcg, 25 mcg, 50 mcg, 100 mcg) or placebo BID for 28 days, and were evaluated for change from baseline in morning trough FEV1 after 28 days of treatment. All study participants receiving LABA or LAMA therapy had their treatment replaced with albuterol MDI as “rescue therapy.” Inhaled corticosteroids and roflumilast were continued throughout the study. The study was sponsored by Sunovion Respiratory Development Inc., a wholly-owned subsidiary of Sunovion Pharmaceuticals Inc.
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
LATUDAis a registered trademark of Sumitomo Dainippon Pharma Co., Ltd. LUNESTA, 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.
SOURCE: Sunovion Pharmaceuticals
Post Views: 42
