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Acura Pharmaceuticals awarded $300,000 grant to develop Rx abuse deterrent technology

BY Michael Johnsen

PALATINE, Ill. — Acura Pharmaceuticals last week announced that it has been awarded a $300,000 grant by the National Institute On Drug Abuse of the National Institutes of Health to fund Phase I development of Acura's new, early stage Limitx abuse deterrent technology. The Grant is based on a proposal submitted by the company to advance the development of a self-regulating hydromorphone tablet intended to deter abuse by excess oral consumption of the tablets.
 
Under the terms of the grant, the company must complete Phase I development by Feb. 28, 2015. Phase I of the project is intended to optimize the formulation in preparation for clinical testing in Phase II. 
 
NIDA funding of Phase II development, for which an application has already been submitted, will be contingent upon assessment by NIDA of the Phase I progress report and determination that the Phase I milestones were achieved, review and approval of other documents necessary for continuation and availability of funds. 
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Study: High-risk hypertension patients can self-regulate condition

BY Michael Johnsen

CHICAGO — Among patients with hypertension at high risk of cardiovascular disease, a program where patients measured their blood pressure and adjusted their antihypertensive medication accordingly resulted in lower systolic blood pressure at 12 months compared with patients who received usual care, according to a study in the Aug. 27 issue of JAMA.
 
Data from national and international surveys suggest that despite improvements over the last decade, significant proportions of patients have poor control of their elevated blood pressure. Self-monitoring of blood pressure with self-titration (adjusting) of antihypertensives results in lower blood pressure in patients with hypertension, but there are no data about patients in high-risk groups, according to background information in the article.
 
Richard McManus of the University of Oxford and colleagues randomly assigned 552 patients with hypertension and a history of stroke, coronary heart disease, diabetes or chronic kidney disease to either self-monitoring of blood pressure combined with an individualized self-titration algorithm or a control group (i.e., patients received usual care consisting of seeing their healthcare clinician for routine blood-pressure measurement and adjustment of medication, if necessary).
 
After 12 months, the average systolic blood pressure decreased in both groups, but was lower in the intervention group. Imputation for missing values showed a marginally lower average difference in systolic blood pressure of 8.8 mm Hg. The reduction in diastolic blood pressure also was greater in the self-monitoring group. The results were comparable in all subgroups, without excessive adverse events.
 
"This trial has shown for the first time, to our knowledge, that a group of high-risk individuals, with hypertension and significant cardiovascular comorbidity, are able to self-monitor and self-titrate antihypertensive treatment following a pre­specified algorithm developed with their family physician and that in doing so, they achieved a clinically significant reduction in systolic and diastolic blood pressure without an increase in adverse events," the authors wrote. "This is a population with the most to gain in terms of reducing future cardiovascular events from optimized blood pressure control."
 
 
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Asthma market to reach $23.1 billion due to targeted biologics

BY Michael Johnsen

LONDON — The asthma treatment market value will grow from approximately $15.9 billion in 2013 across eight major countries — the United States, United Kingdom, France, Germany, Spain, Italy, Japan and Australia — to $23.1 billion by 2023, according to research and consulting firm GlobalData.
 
The company’s latest report states that this increase, which represents a compound annual growth rate of 3.8%, will be driven largely by the expanding share of targeted biologics in the treatment of severe asthma.
 
“While the market share of fixed-dose combinations of inhaled corticosteroids and long-acting beta-agonists will shrink from almost half to 23%, targeted biologics will enter the market and start dominating the asthma space, accounting for 32% of total sales in 2023 from just 8.7% in 2013," stated Valentina Gburcik, senior analyst for GlobalData. “The uptake of these novel drugs will offset the dip in sales caused by the recent patent expiry of Singulair, and that of numerous short-acting beta-agonist, ICS, and ICS/LABA products.”
 
The current late-stage asthma pipeline is dominated by biologics that target various inflammatory pathways in specific patient subpopulations. GlobalData states that the companies with the strongest drug pipelines are GlaxoSmithKline, AstraZeneca, Teva, Roche and Regeneron/Sanofi.
 
“While the subpopulations targeted by pipeline biologics are limited in size, these novel agents will begin to fulfill the important unmet need for a personalized approach to the treatment of severe asthma," Gburcik said. “Despite the development of these biologics, a significant growth opportunity will persist for new patented products, especially lower-priced drugs with more convenient dosing, which will improve patient compliance.”
 
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