FDA Approves Cialis(R) (tadalafil) For Once Daily Use For The Treatment Of Erectile Dysfunction
1 May, 2008
Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Cialis(R) (tadalafil)(1) for once daily use (2.5 mg and 5 mg), an oral medication taken once per day to treat erectile dysfunction (ED). When Cialis for once daily use is taken daily, men can attempt sexual activity at anytime between doses.
Currently available in parts of Europe, this low-dose daily treatment option of Cialis may be most appropriate for men with ED who anticipate more frequent sexual activity (e.g. twice weekly). For other men, Cialis taken as needed - the previously approved dosing regimen - may be most appropriate.
In clinical trials, when taken without restrictions on the timing of sexual activity, Cialis for once daily use improved erectile function over the course of therapy.
"ED can be a chronic condition like diabetes or high blood pressure," said Ridwan Shabsigh, M.D., Director of the Division of Urology at Maimonides Medical Center in New York. "As a urologist, I know couples like to have choices and will appreciate the availability of Cialis for once daily use."
Cialis for use as needed transformed the U.S. ED market when it was approved in 2003 as the first and only PDE5 inhibitor clinically proven to provide sustained efficacy for up to 36 hours. Cialis for once daily use provides a new option for men who may be looking for a dosing option that can be taken without regard to timing of sexual activity. In consultation with their physician, patients now have the freedom to choose the dosing regimen that is appropriate for them.
"We strive to provide patients with solutions that fit their needs and Cialis for once daily use delivers on this promise," said Shawn Heffern, Cialis U.S. Director of Brand Marketing at Lilly. "Now, patients have two options - some may prefer the up to 36 hours of efficacy provided by Cialis for use as needed while others may want the unique benefit provided by this daily dosing option."
Additionally, Lilly's wholesale pricing for Cialis for once daily use will be comparable to Cialis for use as needed such that patients who currently use two or more pills per week of Cialis for use as needed should not experience higher treatment costs with Cialis for once daily use.
The FDA's approval of Cialis for once daily use was based upon the evaluation of the comprehensive data package for the daily dosing option. The data include results from three phase III randomized, double-blind, placebo- controlled studies. Men with ED who participated in these clinical studies and who took tadalafil 2.5 mg and 5 mg once daily without regard to their timing of sexual activity experienced improved erectile function compared with those taking placebo.(2) Cialis 5 mg, 10 mg and 20 mg have been approved in the United States for as-needed treatment of ED since November 2003.
The most commonly reported adverse events were headache, indigestion, back pain, muscle aches, nasal congestion, flushing and pain in limb. Most adverse events reported with tadalafil were transient and generally mild or moderate.
About ED
ED is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. Experts believe that 80 percent to 90 percent of ED cases are related to a physical or medical condition, such as diabetes, cardiovascular diseases, and prostate cancer treatment, while 10 percent to 20 percent are predominantly due to psychological causes.(3,4) In many cases, however, both psychological and physical factors contribute to the condition.(5)
About Cialisz
Cialis(R) (tadalafil) is approved for the treatment of erectile dysfunction on an as-needed basis or in a daily regimen. The recommended starting dose of Cialis for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity. The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. As part of a daily regimen, Cialis may be taken as 2.5 mg or increased to 5 mg, based on individual efficacy and tolerability.
Important Safety Information for Cialis
Cialis is available by prescription only and is not for everyone. Men should discuss their medical conditions and all medications with their doctors to ensure Cialis is right for them and that they are healthy enough for sexual activity. Men taking nitrates, often used for chest pain, should not take Cialis. Such a combination could cause a sudden, unsafe drop in blood pressure. Cialis for once daily use provides continuous plasma tadalafil levels which should be considered when evaluating the potential for interactions with certain medications (e.g., nitrates, alpha-blockers, anti- hypertensives and potent inhibitors of CYP3A4) and with substantial amounts of alcohol. The most common side effects with Cialis were headache, upset stomach, delayed backache or muscle ache.
As with any ED tablet, in the rare event of priapism (an erection lasting more than four hours), men should seek immediate medical attention to avoid long-term injury.
In rare instances, men taking prescription ED tablets (including Cialis) reported a sudden decrease or loss of vision or hearing (sometimes with ringing in the ears and dizziness). It's not possible to determine if these events are related directly to the ED tablets or to other factors. If a man has a sudden decrease or loss of vision or hearing, he should stop taking any ED tablet and seek medical attention right away.
Cialis does not protect a man or his partner from sexually transmitted diseases, including HIV. Men should not drink alcohol in excess with Cialis. Individual results may vary. Cialis has not been studied for multiple attempts per dose.
Individual results may vary. Cialis has not been studied for multiple attempts per dose. For full patient information and/or full prescribing information, visit http://www.cialis.com.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own world-wide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at http://www.lilly.com. P-LLY
Certain of the matters discussed herein with respect to clinical studies and Lilly's products may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on current expectations, estimates and projections about the industry, management beliefs and certain assumptions made by management. Investors are cautioned that matters subject to forward- looking statements involve risks and uncertainties, including economic, competitive, governmental, technological and other factors discussed in the respective filings with the Securities and Exchange Commission, which may affect the business and prospects of Lilly. More specifically, there can be no assurance that this product will achieve commercial success or that competing products will not pre-empt any market opportunity that might exist for the product.
http://www.medicalnewstoday.com/articles/93391.php
Viagra, Cialis and Levitra Get New FDA Labelling, Slight Risk of Eye Problems
25 May, 2007
The Food and Drug Administration today approved updated labeling for Cialis, Levitra and Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.
FDA advises patients to stop taking these medicines, and call a doctor or healthcare provider right away if they experience sudden or decreased vision loss in one or both eyes. Further, patients taking or considering taking these products should inform their health care professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again.
At this time, it is not possible to determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems. The new labeling information is available along with additional information for healthcare providers and consumers online at:
http://ibdcrohns.about.com/cs/prescriptiondrugs/a/genericdrugs.htm
Health Focus: Are Generic Drugs As Good?
13 Oct, 2006
They’re cheaper. And they’re usually as effective. But there are important exceptions.
INTELIHEALTH FEATURE - You’ve seen them in the supermarket: No-name or store brand medications that promise to be as effective and cheaper than the brand-name variety. They can cost half as much as a name brand. But are they as effective?
In most cases, the answer is "yes," says Vincent Earl Pearson, Pharm. D., clinical coordinator for drug information for the Department of Pharmacy at Johns Hopkins Hospital. Generic drugs are as safe and effective as brand-name products, and subject to the same quality guidelines set by the Food and Drug Administration to ensure their therapeutic equivalence.
"There is a long list of generic products that I have no problem putting side-by-side with their brand-name counterparts," says Dr. Pearson. "They’re not inferior. People mistakenly believe cost is equivalent to quality."
Generic drugs must contain an identical amount of active ingredients as their brand-name counterparts, and in the identical dosage. The generic drug must deliver the same amount of those active ingredients into a patient’s bloodstream and within the same time frame as the original drug. It must also fall in "acceptable parameters" established by the FDA for bioavailability, which is the extent and rate at which the body absorbs the drug.
So besides price, the only real difference between brand-name and generic drugs tends to be the inactive ingredients used that have no medicinal value. These include fillers, binders, coloring and flavoring, which may explain why generics may differ in the size or shape of pills or capsules.
Then why do brand-name drugs cost so much more? Their manufacturers must bear the up-front costs of researching and developing the drug, a process that can cost hundreds of millions of dollars. Here's how it works: When the new chemical formula is first synthesized in the lab, the company is issued a patent that lasts 17 years. During that time, no other drug manufacturer can market a generic equivalent of that drug.
But since it can take 10 years or more of testing and clinical trials before the drug gets FDA approval, little time is left for the brand-name manufacturer to recover the costs of its new drug. Once the patent ends, other pharmaceutical companies are free to manufacture and market the drug under another name, subject to FDA approval.
Enter the generic manufacturers. Since the chemical composition of the original drug is part of the public record, outside companies can replicate its formula — and sell it under its own name or under the label of a supermarket or department store chain. Sometimes, the original pharmaceutical company will produce its drug in another form in an effort to stay in the market.
These off-brands have the same active ingredients, strength and dosage as their brand-name counterparts. "The only difference between the drugs is that the manufacturer of the generic product does not have to prove to the FDA that it is safe and effective, because that already has been done," says Dr. Pearson. "The approval process of a generic drug takes much less time, usually within about two years from the time the company decides to manufacture it."
So should you always go generic? Not necessarily, says Dr. Pearson. Patients often wonder whether it is dangerous to switch from a generic product if they have been taking a name-brand product. Switching is usually safe — but there are exceptions.
Some drugs, both brand-name and generic, have what is known as a "Narrow Therapeutic Index (NTI)." That means the drug can produce toxic side effects or loss of disease control if it is absorbed or released at even the slightest changes in doses — whether too high or too low. Remember, there are "parameters" for bioavailability that must be met, not an exact number.
This is why many pharmacists, including Dr. Pearson, are unwilling to substitute generic products for drugs with an NTI. "Even the slightest change can result in upsetting the patient’s disease control," he says. "That’s why I would recommend against switching for such drugs. There’s a real possibility that it might upset a patient’s stability. It could be absorbed differently; it could have fillers or dyes that change the absorption or release of the dosage. While there may be side effects to switching, I have no knowledge of it ever being fatal. If there is a switch, it is essential to continually monitor the drug levels in the blood to make sure there is a minimal risk of toxicity.”
Among the drugs known to have an NTI:
- Conjugated estrogen (Premarin), prescribed as hormone replacement therapy for prevention of osteoporosis or heart disease risk.
- Phenytoin (Dilantin) and carbamazepine (Tegretol), anticonvulsants.
- Theophylline (Theo-dur), for asthma and lung diseases.
- Cyclosporine (Sandimmune or Neoral), used as an organ transplant antirejection drug.
Aside from the NTI drugs, it's usually safe to go with a generic drug, which is why some insurance companies will only pay for generic drugs or require an explanation if a doctor or pharmacist insists on a name-brand product. "A patient can say they do not want generic products," says Dr. Pearson. "But that means the insurance company will make them pay the difference in price, and in many cases that can be a substantial amount. Insurance companies may want the patient to pay the whole price. Then you will have to look for an insurance company with a more reasonable co-payment plan. Patients should keep a tight rein on what their insurance company is doing. Read the material they send you in the mail to look for any changes in the policy."
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