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08/01/2020
Introduction: Vaniqa™ is a prescription drug which was recently approved by the FDA in the United States for treating excessive facial hair in women, which is often part of hirsutism. It may be a welcome alternative for some of the estimated 20 million American women for whom this problem is considered serious enough to warrant tweezing, waxing, or shaving at least once a week for hair removal. Vaniqa is actually not a brand new drug, but rather a new topical-use version of the older drug eflornithine (brand name Ornidyl). It was developed jointly by Gillette and Bristol-Myers Squibb, and was approved on July 31, 2020. Ornidyl, the older drug, was approved in the U.S. in 1990 and is used to treat tropical protozoal diseases and some types of African sleeping sickness. Vaniqa, like Viagra, is considered to be a "lifestyle drug", a drug which generally improves our quality of life, but is not considered to be essential for good health. It doesn't work for everybody, though. Approximately 32% of the 393 patients treated with Vaniqa in the pre-release clinical trials showed marked improvement, compared to only 8% of the 201 control patients who used the vehicle (placebo) alone.
Description: Technically speaking, Vaniqa is a cream containing 13.9% (139 mg/g) of anhydrous eflornithine hydrochloride as eflornithine hydrochloride monohydrate (150 mg/g).
Indications and Usage: Vaniqa (eflornithine hydrochloride) cream is indicated for the reduction of unwanted facial hair in women. Vaniqa has only been studied on the face and adjacent involved areas under the chin, and usage should be limited to those areas.
How Vaniqa Works: Vaniqa probably works by inhibiting an enzyme in human skin that stimulates hair growth. It is not a hair remover or depilatory, but most likely decreases hair growth and exerts antitumor effects and antiprotozoal effects by the same mechanism. Specifically, Vaniqa causes irreversible inhibition of the enzyme ornithine decarboxylase, which is necessary for cell growth and division in mammals. Rapidly dividing cells, such as hair cells, appear to be most susceptible to the effects of the drug.
Effectiveness: Approximately 32% of the 393 female patients treated with Vaniqa in the clinical trials showed marked improvement (reduction of unwanted facial hair), compared to only 8% of the 201 control patients who used the vehicle (placebo) alone. These results are based on the pre-release clinical trials, in which Vaniqa was used twice daily for 24 weeks. Improvement was often seen in as few as four to eight weeks of treatment. After discontinuing Vaniqa treatment, facial hair growth approached pre-treatment levels within eight weeks.
Safety and Side Effects: Observed side effects of Vaniqa in the clinical trials were relatively mild. They included temporary redness, stinging, burning, tingling, rash, "razor bumps," and acne. These side effects were observed in the clinical studies, which used a relatively small number of women, and it's unlikely that very rare side effects would have been detected in those studies. More serious side effects, similar to those which occur when the drug is used for African sleeping sickness, would be expected if the drug were ingested orally, or used excessively (multiple tubes per day) on non-facial areas of the body. Vaniqa is classified as "pregnancy category C", which, in this case, means that animal studies have shown that it has an adverse effect on the fetus but there are no adequate studies in humans. For practical purposes, that means to avoid the drug during pregnancy unless it's absolutely necessary.
Conclusions: Although unwanted facial hair in women is not a serious illness, it is often part of hirsutism and can be very disconcerting to those women who have it. Vaniqa is the first prescription drug approved in the United States to treat this condition. It was effective, compared to placebo, in approximately 25% of women who used it during the pre-release clinical trials. Although Vaniqa currently appears have few side effects, when used as directed, post-release experience often modifies the safety profile for new drugs. Potential risks of using a new drug should be carefully compared to the benefits to be derived before using this drug for it's effect on excessive facial hair.
References:
· Drugs for Parasitic Infections, Med Lett Drugs Ther, 1993, 35(911):111-22.
· Vaniqa Prescribing Information From the FDA. Requires the Adobe Acrobat Reader (free download).
· Monographs on "eflornithine" from Clinical Pharmacology 2000 and The Worldwide Drug Database. Access to each is free, but requires an extensive registration procedure.
Press Release: Princeton, New Jersey, July 31, 2000 - Bristol-Myers Squibb Company (NYSE:BMY) and The Gillette Company (NYSE:G) announced today that the U.S. Food and Drug Administration (FDA) has approved Vaniqa™ (eflornithine hydrochloride) Cream, 13.9% as the first topical prescription treatment for women with unwanted facial hair. Vaniqa works by inhibiting the growth of facial hair, and was shown in controlled clinical trials to provide clinically meaningful and statistically significant improvement in the reduction of facial hair growth in women.
The FDA approval of Vaniqa may provide an important new option for the more than 41 million women in the United States with unwanted facial hair. Unwanted facial hair can affect women of all ages, races and ethnic backgrounds. The impact of this surprisingly common problem extends beyond the need for regular tweezing, waxing or depilatory application. Many women who have unwanted facial hair often report that the condition negatively impacts their lifestyle and makes them feel unfeminine and less confident.
"As a physician, I am excited about the potential for this new prescription cream to help women manage unwanted facial hair," said Marty E. Sawaya, M.D., PhD, adjunct professor, Department of Biochemistry and Molecular Biology, University of Miami, and a dermatologist and clinical research investigator at ARATEC Clinics in Ocala, Florida. "Importantly, Vaniqa will potentially help millions of women with this condition to feel less bothered by their facial hair and the amount of time they spend removing, treating or concealing it."
Vaniqa (eflornithine hydrochloride) Cream, 13.9% was developed through a unique partnership between The Gillette Company and Bristol-Myers Squibb. The companies formed the partnership in 1996 in order to complete development of the product. Bristol-Myers Squibb is responsible for worldwide clinical development, regulatory submissions and, together with Gillette, is responsible for marketing this prescription product.
"Bristol-Myers Squibb is pleased that the FDA has approved Vaniqa as the first lifestyle prescription drug available to treat unwanted facial hair," said Richard J. Lane, president, Worldwide Medicines Group, Bristol-Myers Squibb. "As a result of our partnership with The Gillette Company, we can now provide physicians with an effective way to help their patients who are affected by this problem."
In most cases, unwanted facial hair is caused by hereditary factors. A small number of cases are caused by medical conditions such as androgen excess disorder or polycystic ovarian syndrome. Regardless of the cause, Vaniqa (eflornithine hydrochloride) Cream, 13.9% demonstrated in clinical trials that it is effective in slowing the growth of unwanted facial hair in up to 60 percent of women. Vaniqa takes up to 2 months to work, and along with Vaniqa, women should continue to use their current method of hair removal.
Vaniqa has a unique mechanism of action and is believed to work by blocking an enzyme that is necessary for hair growth. In Phase III clinical trials, the primary study measure was a physician's global assessment of their patients' improvement at the end of 24 weeks. Results demonstrated clinically and statistically significant improvement in the reduction of facial hair growth in women treated with Vaniqa as compared to the group that was treated with vehicle (a placebo cream). Significant differences between Vaniqa and vehicle were seen as soon as eight weeks into treatment. The data from the Phase III clinical studies show that among those who completed 24 weeks of treatment, nearly 60 percent of patients on Vaniqa improved.
In clinical trials, when side effects occurred they were mild and generally resolved without treatment. The most common side effects associated with Vaniqa were minor skin irritations such as temporary redness, hair bumps, stinging, burning, tingling, acne, or rash.
"Until now, no prescription creams have been available that help slow the rate of unwanted hair growth," said Mary Ann Pesce, vice president, New Products, The Gillette Company. "This unique partnership with Bristol-Myers Squibb reflects the ongoing commitment of The Gillette Company to develop products specifically designed to meet the grooming and beauty needs of women."
Women who are interested can learn more about Vaniqa by consulting with their physician or by calling 1-877-829-9715. Vaniqa will be available in pharmacies as early as September.
SOURCE: Bristol-Myers Squibb
FDA Approves Facial Hair Treatment -Tracee Cornforth- © 2000 About.com
The FDA has approved an important new treatment option for the more than 41 million women in the United States with unwanted facial hair. Unwanted facial hair affects women of all ages, races, and ethnic backgrounds.
The problem of unwanted facial hair extends beyond the normal need for tweezing, waxing, or depilatory application. Many women with excess facial hair suffer negative impact on their lifestyle that often makes them feel unfeminine and less confident.
The Bristol-Myers Squibb Company and The Gillette Company announced the FDA approval of Vaniqa™ (eflornithine hydrochloride) Cream, 13.9% as the first topical prescription treatment for women with unwanted facial hair. Vaniqa works by inhibiting the growth of facial hair. In controlled clinical trails, the drug was shown to clinically meaningful and statistically significant improvement in the reduction of facial hair growth in women.
"As a physician, I am excited about the potential for this new prescription cream to help women manage unwanted facial hair," said Marty E. Sawaya, M.D., Ph.D., adjunct professor, department of biochemistry and molecular biology, University of Miami, and a dermatologist and clinical research investigator at ARATEC Clinics in Ocala, Florida. "Importantly, Vaniqa will potentially help millions of women with this condition to feel less bothered by their facial hair and the amount of time they spend removing, treating, or concealing it."
A unique partnership, formed in 1996, between The Gillette Company and Bristol-Myers Squibb led to the development of Vaniqa Cream, 13.9%. Bristol-Myers Squibb is responsible for worldwide clinical development, regulatory submissions and, together with Gillette, is responsible for marketing this prescription product.
"Bristol-Myers Squibb is pleased that the FDA has approved Vaniqa as the first lifestyle prescription drug available to treat unwanted facial hair," said Richard J. Lane, president, Worldwide Medicines Group, Bristol-Myers Squibb. "As a result of our partnership with The Gillette Company, we can now provide physicians with an effective way to help their patients who are affected by this problem."
Hereditary factors are usually the cause of unwanted facial hair in women; however a small number of cases are caused by medical conditions such as androgen excess or polycystic ovary syndrome. Vaniqa Cream 13.9% demonstrated in clinical trials that it is effective in slowing the growth of unwanted facial hair in up to 60 percent of women without regard to cause.
Vaniqa can take up to 2 months to work, and women should continue to use their current hair removal method until the drug is working effectively. Vaniqa has a unique mechanism of action and is believed to work by blocking an enzyme that is necessary for hair growth.
After 24 weeks, patients in Phase III clinical trials, saw significant improvement in the reduction of facial hair growth in women treated with Vaniqa as compared to the group that was treated with vehicle (a placebo cream). Significant differences between Vaniqa and vehicle were seen as soon as eight weeks into treatment. The data from the Phase III clinical studies show that among those who completed 24 weeks of treatment, nearly 60 percent of patients on Vaniqa improved.
Side effects were mild and usually resolved without treatment. Minor skin irritations such as temporary redness, hair bumps, stinging, burning, tingling, acne, or rash were the most common side effects associated with Vaniqa.
Vaniqa is the first prescription cream available to help slow the rate of unwanted hair growth. Women can learn more about Vaniqa by consulting their physicians or by calling 1-877-829-9715. Vaniqa is expected to be available in pharmacies in September.
NEW YORK (AP) - They pluck, they bleach, they tweeze. They use hot wax, electric current and lasers. Some even shave daily. And still the hair comes back.
About one in six American women has enough facial hair that they remove it at least once a week.
Now, Gillette Co., the world's biggest manufacturer of razors, and pharmaceutical maker Bristol-Myers Squibb Co. have developed the first prescription cream that stops the growth of facial hair in women.
The drug could win Food and Drug Administration approval as early as next year.
Vaniqa (pronounced van-ih-KAH) is applied to the face like a moisturizer twice a day. It works by blocking the enzyme that makes hair grow. It must be used regularly or hair growth will resume. Studies show it helps most women and has no major side effects.
Vaniqa appears to work in men as well - but the makers are trying to prove themselves with women first.
Facial hair in women has several causes, including an excess of male hormones. Genetics can also play a role. For instance, women of Mediterranean or Hispanic descent tend to have more facial hair.
The condition, known medically as hirsutism, can damage a woman's self-esteem. ''It's very destructive, psychologically,'' said Dr. Ricardo Azziz, professor of obstetrics and gynecology at the University of Alabama-Birmingham.
Azziz said current treatments are only moderately successful, and Vaniqa may be preferable because creams cause fewer side effects.
No one has to convince Ingrid Reyes, 29, a chemist from New York City. Reyes said she has had sideburns and dark hair above her lip since she was a teen-ager.
''I've been on a date and suddenly he notices it and says, 'You have a lot of hair.' He doesn't mean any harm, but it makes you feel uncomfortable,'' she said.
Reyes tried waxing to remove the hair. But that dried out her skin. She tried plucking it. But the hair only grew back thicker.
Lately she has been receiving electrolysis, which gets rid of hair permanently by delivering electrical current through a needle placed into the hair follicle. But multiple treatments are required and - at $75 each - they are stretching her budget.
Other methods also have shortcomings. Shaving causes stubble and skin may become irritated. Depilatories, or creams that remove hair, can irritate the skin.
Some physicians have prescribed birth control pills, but many women don't want to take them because they can cause weight gain and other side effects. Physicians recently started using lasers to kill hair follicles but that is also expensive, and can cause scarring.
''It will be nice to give women something they do not have to take by mouth, and it's certainly less painful than electrolysis,'' said Dr. Ken Washenik, a dermatologist at New York University who helped study the drug. The only side effect was a rash on some women, he said.
The companies have not set a price yet for Vaniqa. Like other ''lifestyle'' drugs such as those that fight baldness, the cream probably won't be covered by insurance.