Higher-Dose Alzheimer’s Drug Gets FDA Approval
A new once-daily, higher dose Aricept® (donepezil HCl) 23-mg tablet has been approved by the U.S. Food and Drug Administration for the treatment of moderate-to-severe Alzheimer’s disease (AD).
On the basis of the approved label, the recommended starting dosage of Aricept is 5 mg once daily and can be increased to 10 mg once daily after 4 to 6 weeks. Patients with moderate-to-severe AD who are established on a regimen of Aricept 10 mg for at least 3 months are candidates for dosage escalation to 23 mg.
The approval of Aricept 23 mg is based on data from a large head-to-head, randomized, double-blind, controlled, parallel-group clinical study of Aricept 23 mg versus Aricept 10 mg in 1,467 patients with moderate-to-severe AD who had been treated for 3 months or more with Aricept 10 mg. Two co-primary endpoints were examined: the Severe Impairment Battery (SIB), which measures cognition, and the Clinician’s Interview-Based Impression of Change Plus Caregiver Input (CIBIC+), which measures global function. Aricept 23 mg demonstrated a statistically significant improvement in cognition but did not achieve statistically significant improvement in global function, as compared with Aricept 10 mg tablet.
The change in total scores from baseline to Week 24 on the SIB was 2.6 points in the Aricept 23 mg group compared with 0.4 points in the 10 mg group, resulting in a statistically significant treatment difference. This was based on data from the intent-to-treat (ITT) population (n = 1,371 patients, p = 0.0001), with similar results for an analysis using data from the 1,084 patients who finished the study.
For the CIBIC+, the overall change score at Week 24 was 4.23 in the Aricept 23 mg group compared with 4.29 in the 10 mg group (ITT, p = 0.1789), but this difference was not statistically significant.
Source.“Eisai Inc. and Pfizer Inc. Announce U.S. FDA Approval for New Higher-Dose Aricept (Donepezil HCl) 23 mg Tablet for the Treatment of Moderate-to-Severe Alzheimer’s Disease.” (2010, July 24). Retrieved August 20, 2010, from http://www.eisai.com/view_press_release.asp?ID=147&press=280.
New Labeling on Injectable Drugs to Benefit Patient Safety
To reduce the likelihood of patient death and disability resulting from errors in the administration of injectable medications in hospitals and other health care settings, the U.S. Pharmacopeial Convention (USP), the official standards-setting body for medicines and their ingredients in the United States, is advancing new labeling requirements that will standardize the information permitted on the highly visible area of these vials to only cautionary statements intended to prevent imminent life-threatening situations. For medications in which no cautionary statement is necessary, this area of the vial will be required to remain blank, precluding company logos, company names, and other information from being printed in these locations.
Reports from the Institute of Medicine, the National Coordinating Council for Medication Error Reporting and Prevention, the Institute for Safe Medication Practices, and others have indicated that labeling of injectable products may be linked to medication errors in the administration of these products. Patient safety data from U.S. hospitals have indicated that the most severe medication errors for injectable products were predominantly related to human performance deficits, occurring most often at the time of administration, with environmental distractions as the major contributing factor.
The new requirements apply to the top (circle) surface of the ferrule and cap overseal of a vial containing an injectable medication. According to the U.S. Food and Drug Administration (FDA), if manufacturers believe they need to include a cautionary statement about an imminent life-threatening situation on the ferrule or cap overseal of their product, manufacturers will need to provide a rationale to FDA for why the situation addressed in the statement is considered to be life threatening. Other information will still be permitted to appear elsewhere on the medication vials.
Source.“New Standard for Labeling on Injectable Medications Designed to Reduce Likelihood of Patient Death, Disability.” (2010, August 4). Retrieved August 19, 2010, from http://www.eurekalert.org/pub_releases/2010-08/up-nsf080410.php.
3-in-1 Combination Gets FDA Approval for Hypertension
The U.S. Food and Drug Administration (FDA) has approved Tribenzor™ (olmesartan medoxomil, amlodipine, hydrochlorothiazide), a new three-in-one, once-daily combination product for the treatment of hypertension in patients whose condition is not adequately controlled on any two of the following antihypertensive drug classes: angiotensin receptor blockers, calcium channel blockers, and diuretic agents. Tribenzor is not indicated for initial therapy.
Tribenzor combines three widely prescribed antihypertensive medications: the complementary actions of olmesartan medoxomil (which blocks angiotensin II receptors), amlodipine (which inhibits the entrance of calcium into the blood vessel walls), and hydrochlorothiazide (a diuretic agent that reduces water volume in the blood).
After 8 weeks of treatment, Tribenzor produced highly statistically significantly greater reductions in both systolic and diastolic blood pressures compared with each of the three dual combination therapies. According to the Tribenzor pivotal registration trial that included a total of 2,492 patients with hypertension (mean baseline blood pressure = 168.5/100.9 mm Hg), the switch to Tribenzor 40/10/25 mg from each of the following three dual combination therapies—amlodipine/hydrochlorothiazide 10/25 mg, olmesartan/hydrochlorothiazide 40/25 mg, and olmesartan/amlodipine 40/10 mg—yielded a further mean reduction after 8 weeks of treatment in systolic/diastolic blood pressure of 8.1/5.4 mm Hg, 7.6/5.4 mm Hg, and 8.4/4.5 mm Hg, respectively (p < 0.0001 versus each dual combination therapy).
Source.“FDA Approves Tribenzor, A New Three-in-One Combination Product for the Treatment of High Blood Pressure.” (2010, July 26). Retrieved August 19, 2010, from http://www.pharmalive.com/News/index.cfm?articleid=719277&categoryid=29.
Phase III Study Shows Promise for Investigational Chronic Pain Drug
A study comparing tapentadol extended release (ER) tablets, an investigational pain medication, to an existing prescription pain medication, oxycodone controlled release (CR) tablets found tapentadol ER was associated with a lower overall incidence of gastrointestinal adverse events than oxycodone CR (tapentadol ER, 52%; oxycodone CR, 64.1%) in patients with chronic knee or hip osteoarthritis pain or chronic low back pain.
In this Phase III open-label study, published in Pain Practice, the median duration of treatment was substantially longer with tapentadol ER (268 days) than with oxycodone CR (59 days), and the incidence of overall gastrointestinal treatment-emergent adverse events leading to study discontinuation was approximately 2.5 times greater in the oxycodone CR group than in the tapentadol ER group (oxycodone CR, 21.5%; tapentadol ER, 8.6%).
The study also found tapentadol ER provided sustainable relief of moderate to severe chronic knee or hip osteoarthritis pain or chronic low back pain for up to 1 year. At baseline, mean pain intensity scores in the tapentadol ER and oxycodone CR groups were 7.6 and 7.6, respectively; at endpoint, they had decreased to 4.4 and 4.5.
This study of tapentadol ER examined its long-term safety and tolerability compared with oxycodone CR, and the primary objective was to evaluate the safety of twice-daily dosages of tapentadol ER (100 mg to 250 mg) over 1 year. Patients were randomized in a 4-to-1 ratio to receive controlled, adjustable, oral, twice-daily dosages of tapentadol ER (100 mg to 250 mg) or oxycodone HCl CR (20 mg to 50 mg) in open-label treatment for up to 1 year. There were 1,117 patients in the study who received at least one dosage of study medication (tapentadol ER, n = 894; oxycodone CR, n = 223). Demographic and baseline characteristics were similar in the two treatment groups.
Nucynta® (tapentadol immediate release) was approved by the U.S. Food and Drug Administration in 2008 and is available by prescription only for the relief of moderate to severe acute pain in patients 18 and older. A New Drug Application for tapentadol ER tablets was submitted to the FDA in December 2009 for the management of moderate to severe chronic pain in patients 18 and older.
Source.“Phase 3 Open-Label Study Comparing Tapentadol Extended Release Tablets to Oxycodone Controlled Release Tablets Published by Pain Practice.” (2010, July 19). Retrieved July 28, 2010, from http://www.drugs.com/news/phase-3-open-label-study-comparing-tapentadol-extended-release-oxycodone-controlled-release-25617.html.