From staff reports

 is making it easier for pharmacists and healthcare professionals to look up drug information by launching an online scientific resource tool.

, is available to view on computers, tablets, and smartphones.

"JanssenMD was created to provide healthcare professionals with theinformation they need, when, where, and how they need it," said Dr. NormRosenthal, Chief Scientific Officer, Janssen Scientific Affairs, LLC.

The online resource provides prescribing information, clinical trial data, and safety information about Janssen medications, according to a press release.

"This unique digital platform enables us to respond to healthcare professionals'questions with information that is current, accurate, and instantlyaccessible from any device they are using," Rosenthal said.

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Janssen Pharmaceuticals, Inc. is making it easier for pharmacists and healthcare professionals to look up drug information by launching an online scientific resource tool.

New online tool available for Janssen products

, Abbott) for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis (UC) when certain other medicines have not worked well enough. Combined with its approval to treat moderate-to-severe Crohn's disease, adalimumab is now approved for the treatment of the 2 primary diseases that comprise inflammatory bowel disease.

Adalimumab works by inhibiting tumor necrosis factor-alpha (TNF-α). The UC approval represents the seventh indication for this treatment in the United States and makes adalimumab the first and only self-administered biologic treatment approved for use in this disease. It is not known if adalimumab is effective in people with moderate to severe UC who have lost response to or could not tolerate anti-TNF medicines. Adalimumab can be self-administered after proper injection training is received and with proper physician monitoring.

"There is significant unmet medical need in this patient population, which has not seen a new treatment approved in more than seven years," William J. Sandborn, MD, division chief, gastroenterology, University of California, San Diego, said in an Abbott press release. "This FDA approval is good news for patients and health care professionals who are seeking another option to manage the disease."

UC is a chronic disease that is marked by inflammation and ulceration in the lining of the colon or large intestine. It is estimated that approximately 700,000 people in the United States have UC. On average, people are diagnosed with UC in their mid-30s, though the disease can occur at any age. Symptoms include abdominal cramping, rectal bleeding, diarrhea, and urgency and frequency to have a bowel movement. The symptoms of UC tend to come and go, with periods of remission between flare-ups. Treatment may include medication and surgery.

It is also important that UC patients properly manage their nutrition because fluids, nutrients and electrolytes can be lost due to rectal bleeding and diarrhea. Additionally, 25% of UC patients will require surgery during the course of the disease.

FDA previously approved Humira to treat rheumatoid arthritis (2002), psoriatic arthritis (2005), ankylosing spondylitis (2006), Crohn’s disease (2007), plaque psoriasis (2008), and juvenile idiopathic arthritis (2008).

Abbott's submission for Humira was supported by results from 2 phase 3 studies, ULTRA 1, an 8-week study, and ULTRA 2, a 52-week study, both of which enrolled adult patients who had moderately to severely active UC despite concurrent or prior treatment with immunosuppressants (ie, corticosteroids, azathioprine, or 6-mercaptopurine).

The primary end point of both studies was the proportion of patients achieving clinical remission at specified time points (week 8 in ULTRA 1 and weeks 8 and 52 in ULTRA 2). Remission was defined as a Mayo score of ≤ 2 and no individual subscore > 1. The Mayo score is calculated based on subscores of stool frequency, rectal bleeding, physician's global assessment, and endoscopy. In the FDA-approved dose, both studies achieved their primary end points. The safety results from both studies were consistent with the known safety profile of adalimumab and no new safety signals were identified.

Adalimumab is a TNF blocker medicine that affects the immune system and can lower the ability to fight infections. Serious infections have happened in people taking adalimumab. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before adalimumab use and monitored for signs and symptoms of TB during therapy. People at risk of TB may be treated with medicine for TB. Treatment with adalimumab should not be started in a person with an active infection, unless approved by a doctor. Adalimumab should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, have had TB, hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

For people taking TNF blockers, including adalimumab, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including adalimumab, the chance of getting 2 types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life threatening if treated.

Common side effects of adalimumab include injection-site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea.

FDA has approved adalimumab (Humira, Abbott) for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis (UC) when certain other medicines have not worked well enough. Combined with its approval to treat moderate-to-severe Crohn's disease, adalimumab is now approved for the treatment of the 2 primary diseases that comprise inflammatory bowel disease.

FDA approves Humira to treat ulcerative colitis

) tablets for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with currently available therapies (including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy). 

Regorafenib is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and progression-angiogenesis, oncogenesis, and the tumor microenvironment. 

Regorafenib’s approval is based on results from the pivotal phase 3 (CORRECT [or (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy]) study that demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) compared to placebo in patients with mCRC whose disease had progressed after approved standard therapies. 

 “The US approval of Stivarga is an important milestone for Bayer as it marks the first approval of this innovative cancer treatment to fulfill a significant unmet medical need in the treatment of metastatic colorectal cancer,” Jörg Reinhardt, CEO, Bayer HealthCare, said in a company press release. 

In the CORRECT trial, regorafenib plus best supportive care (BSC) significantly improved OS (HR=0.77, 2-sided 

The most frequently observed adverse drug reactions (≥30%) in patients receiving regorafenib were asthenia/fatigue, decreased appetite and food intake, hand-foot-skin reaction/palmar-plantar erythrodysesthesia, diarrhea, mucositis, weight loss, infection, hypertension, and dysphonia. The most serious adverse drug reactions in patients receiving regorafenib were hepatotoxicity, hemorrhage, and gastrointestinal perforation. Primary efficacy and safety data for this trial were first reported at the Annual Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO-GI) in January 2012 and additional data were presented at the ASCO Annual Meeting in June 2012. 

Stivarga was developed and reviewed under the fast track program and received priority review designation from FDA. 

CRC is the fourth most common cancer worldwide, with more than 1 million cases occurring every year. The mortality rate from CRC is approximately half of its global incidence. The 5-year survival estimate for CRC on average is 55%, but is highly variable dependent on the stage of the disease (from 74% for patients with stage I disease to only 6% for stage IV patients).   In mCRC, KRAS status is an important biomarker and can be a predictor of treatment response. Approximately 40% of colorectal cancers are characterized by mutations in the KRAS gene. Some of the CRC therapies currently available have demonstrated efficacy only in patients without KRAS mutations.  

FDA approved regorafenib (Stivarga, Bayer HealthCare) tablets for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with currently available therapies (including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and if KRAS wild type, an anti-EGFR therapy).

FDA approves regorafenib tablets for treatment of metastatic colorectal cancer

is supporting antibacterial drug development by launching a new internal task force.

"The creation of this new task force comes at a critical time," said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research (CDER) and co-chair of the task force. "Establishing new ways of developing safe and effective new antibacterial drugs is an enormous challenge and not an effort that can be accomplished alone."

The task force will identify priority areas and potential solutions to the challenges of antibacterial drug development, according to the 

. There are 19 CDER  scientists and clinicians on the task force. 

“More than 70% of the bacteria that cause hospital-associated infections (HAIs) are resistant to at least one type of antibacterial drug most commonly used to treat these infections," according to the statement. "In the United States, nearly 2 million Americans developed HAIs in 2002, resulting in about 99,000 deaths."

The task force will help develop and revise guidance related to antibacterial drug development, as required by the Generating Antibiotic Incentives Now (GAIN) Title of the FDA Safety and Innovation Act (FDASIA), which was signed into law July 9.

"By establishing this task force, FDA can help make real progress and change the paradigm," said Rachel Sherman, MD, associate director for Medical Policy in CDER, director of CDER's Office of Medical Policy, and co-chair of the task force in the release. "Our hope is that this effort will result in important new breakthroughs in the field of antibacterial drug development and help in the fight against antibiotic resistance."

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FDA is supporting antibacterial drug development by launching a new internal task force, according to a press release today.

FDA task force to work on antibacterial drug development

FDA has given priority review to an additional indication for lubiprostone (Amitiza, Sucampo Pharmaceuticals and Takeda) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.

FDA’s decision is expected by late January 2013. 

 “One of the most common adverse reactions of opioid medications is opioid-induced constipation, a medical condition for which there are currently no approved oral prescription treatment options available,” Ryuji Ueno, MD, PhD, chairman, chief scientific officer, and chief executive officer of Sucampo, said in a company press release. 

Lubiprostone is a chloride channel activator indicated for the treatment of chronic idiopathic constipation (CIC) (24 µg twice daily) in adults and for irritable bowel syndrome with constipation (IBS-C) (8 µg twice daily) in women aged 18 years and older by FDA in the United States. Lubiprostone is approved in Japan for the treatment of chronic constipation (excluding constipation caused by organic diseases); in Switzerland for CIC; and in the United Kingdom for CIC. 

Lubiprostone is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider to confirm the absence of such an obstruction prior to initiating lubiprostone treatment. 

The safety of lubiprostone in pregnancy has not been evaluated in humans. Lubiprostone should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with lubiprostone and should be capable of complying with effective contraceptive measures.

Patients taking lubiprostone may experience nausea. If this occurs, concomitant administration of food with lubiprostone may reduce symptoms of nausea. Patients who experience severe nausea should inform their healthcare provider. 

Lubiprostone should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and inform their healthcare provider if the diarrhea becomes severe. 

Patients taking lubiprostone may experience dyspnea within an hour of first dose. This symptom generally resolves within 3 hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their healthcare provider. Some patients have discontinued therapy because of dyspnea. 

In clinical trials of lubiprostone (24 µg twice daily vs placebo; N=1,113 vs. N=316) in patients with (CIC, the most common adverse reactions (incidence > 4%) were nausea (29% vs 3%), diarrhea (12% vs In clinical trials of lubiprostone (8 µg twice daily vs. placebo; N=1,011 vs N=435) in patients with IBS-C, the most common adverse reactions (incidence > 4%) were nausea (8% vs 4%), diarrhea (7% vs 4%), and abdominal pain (5% vs 5%).

Reduce the dosage in CIC patients with moderate and severe hepatic impairment. Reduce the dosage in IBS-C patients with severe hepatic impairment.

FDA grants priority review to opioid-induced constipation indication for lubiprostone

Watson Laboratories issued a voluntary nationwide recall for 2 lots of hydrocodone bitartrate and APAP Tablets, USP 10 mg/500 mg.  Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.

A customer complaint was received for tablets that were thicker and darker shade than the other tablets. It is possible that some tablets from lots 519406A and 521759A exceed the weight specification and may contain higher than indicated amounts of the ingredients hydrocodone bitartrate and/or acetaminophen. 

Unintentional ingestion of excessive amounts of acetaminophen may potentially result in an adverse event, including liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. The product label warns consumers that acetaminophen overdose can potentially cause severe liver damage, at times resulting in liver transplant or death. Unintentional ingestion of excessive amounts of hydrocodone may result in an adverse event, including an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, for example other sedating medications or certain antidepressants.  No reports of injuries related to the recalled product have been received to date. 

The recall includes hydrocodone bitartrate and acetaminophen tablets, USP 10 mg/500 mg, 500 count NDC 00591-0540-05, Lot Numbers 519406A and 521759A both with the expiration date April 2014. 

The affected lots were distributed between June 27, 2012 and July 18, 2012 to wholesale distributors and retail pharmacies nationwide.  The lot numbers can be found on the manufacturer's bottle label.  Hydrocodone bitartrate and acetaminophen tablets are approximately 0.6 inches in length, blue, bisected capsule shaped, with 

Consumers who have lots 519406A or 521759A should contact their pharmacy or healthcare professional.  Consumers who are unsure if they have the affected lot numbers should consult their pharmacy or healthcare professional. 

Pharmacists and wholesalers are asked to check their inventories for lots 519406A or 521759A, segregate any material from the lots, and to contact GENCO Pharmaceutical Services at (855) 393-5728 for instructions on product return. Pharmacies that received lots 519406A or 521759A will receive a copy of a Watson 

Watson Laboratories issued a voluntary nationwide recall for 2 lots of hydrocodone bitartrate and APAP Tablets, USP 10 mg/500 mg. Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.