Wednesday, December 21, 2005
How Common Is Onychomycosis (toe fungus) ?
Onychomycosis accounts for 40% to 50% of all nail dystrophies.It has a prevalence in Americans as high as 13%.It is increasing in incidence; T rubrum on the feet of immigrants to the United States from countries with high infection rates may be the cause. The risk of onychomycosis in adults is 30 times higher than in children.
Possible causal factors are peripheral vascular disease, traumatic nail abnormalities, polypharmacy, and poor foot hygiene. Certain activities are linked to onychomycosis. Swimming is a risk factor, perhaps because of prolonged exposure of the nails to moisture, with accompanying cuticle and skin maceration. Further, the floors of locker rooms and swimming facilities are usually heavily contaminated with fungi .Certain medical conditions (e.g., psoriasis, diabetes mellitus, tinea pedis) are risk factors for onchomycosis, as is wearing occlusive or poorly fitting footwear.
Possible causal factors are peripheral vascular disease, traumatic nail abnormalities, polypharmacy, and poor foot hygiene. Certain activities are linked to onychomycosis. Swimming is a risk factor, perhaps because of prolonged exposure of the nails to moisture, with accompanying cuticle and skin maceration. Further, the floors of locker rooms and swimming facilities are usually heavily contaminated with fungi .Certain medical conditions (e.g., psoriasis, diabetes mellitus, tinea pedis) are risk factors for onchomycosis, as is wearing occlusive or poorly fitting footwear.
Tuesday, December 20, 2005
Barrier Therapeutics Announces FDA Acceptance of Its New Drug Application for Sebazole(TM) Topical Gel
Barrier Therapeutics, Inc. (NASDAQ: BTRX), a pharmaceutical company developing and commercializing products in the field of dermatology, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for Sebazole™ (ketoconazole USP 2%) topical gel for the treatment of seborrheic dermatitis. Sebazole is a topical formulation consisting of 2.0% ketoconazole, an antifungal agent, formulated in a waterless gel for once-daily application. The NDA for Sebazole topical gel was submitted to the FDA in September 2005.
"Sebazole is our second product candidate currently under active FDA review, following Vusion™, which is a significant milestone for Barrier," stated Geert Cauwenbergh, Ph.D., Chairman and CEO of Barrier Therapeutics, Inc. "If approved by the FDA, we believe Sebazole will provide significant patient benefits in the non-steroidal management of seborrheic dermatitis, with less risk for irritation and a more convenient treatment regimen as compared to currently available ketoconazole cream products."
The NDA submission for Sebazole was based on the results of a pivotal confirmatory Phase 3 clinical trial in addition to the results from two prior supportive Phase 3 trials. In the confirmatory two arm Phase 3 pivotal study, which enrolled 459 subjects at 24 centers across the United States, Sebazole achieved statistical significance at the primary endpoint as compared to the vehicle treated patients (p=0.001). The study was a double blind, vehicle-controlled study of once-a-day Sebazole treatment compared to the vehicle (the waterless gel formulation alone). Sebazole also achieved statistical significance for the same primary efficacy endpoint in both of the prior Phase 3 clinical trials, which enrolled a combined total of 474 patients in the Sebazole and vehicle arms at 47 centers in the United States and Europe (U.S. study: p < 0.001 and European study: p=0.021). The earlier two Phase 3 studies had four treatment arms (Sebazole, the vehicle alone, the vehicle containing a topical steroid known as desonide, and the combination of desonide with Sebazole). The primary efficacy endpoint for all three Phase 3 studies was the proportion of subjects who were effectively treated at day 28, which is 14 days following the end of a two-week treatment period.
The filing of an NDA with the FDA is an important step in the approval process in the United States. Acceptance for filing by the FDA does not mean that the NDA has been or will be approved, nor does it represent an evaluation of the adequacy of the data submitted.
About Seborrheic Dermatitis
Seborrheic dermatitis is a skin inflammation characterized by a red, scaly, itchy rash primarily occurring on the face, scalp, hairline, eyebrows and trunk. The condition often recurs, thereby requiring re-treatment over time. Seborrheic dermatitis affects approximately 3% to 5% of the U.S. population. Barrier Therapeutics estimates that approximately 8.5 to 14.3 million people in the U.S. are affected. Current prescription therapies consist primarily of topical ketoconazole creams and topical steroids. These treatments typically require multiple applications per day over periods of up to four weeks to be effective.
About Barrier Therapeutics, Inc.
Barrier Therapeutics, Inc. is a pharmaceutical company focused on the discovery, development and commercialization of pharmaceutical products in the field of dermatology. The Company currently markets Solagé® (mequinol 2%, tretinoin 0.01%) Topical Solution in the U.S. and Canada for the treatment of solar lentigines, a common condition also known as "age spots," and markets VANIQA®, (eflornithine hydrochloride) Cream 13.9% for slowing the growth of unwanted facial hair in women in Canada. Barrier has eight product candidates in various stages of clinical development. The four most advanced product candidates include Vusion™ (formerly known as Zimycan™) for the treatment of diaper dermatitis complicated by candidiasis, Sebazole™, for the treatment of seborrheic dermatitis, which are under FDA review, and two other product candidates in Phase 3 for the treatment of onychomycosis and congenital ichthyosis, respectively. Barrier has product candidates in earlier stages of clinical development for the treatment of acne, psoriasis and fungal infections. The Company is headquartered in Princeton, New Jersey and has wholly owned subsidiaries in Geel, Belgium and Ontario, Canada.
Web site: http://www.barriertherapeutics.com.
Safe Harbor Statement
In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of the "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding the potential patient benefits of Sebazole. Forward-looking statements provide Barrier's current expectations or forecasts of future events. Barrier's performance and financial results could differ materially from those reflected in these forward-looking statements due to decisions of regulatory authorities, patient and market acceptance of Sebazole, general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries generally. For a discussion of these and other risks and uncertainties that may effect the forward-looking statements, please see the risk factors in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2005 that is on file with the Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Barrier undertakes no obligation to update publicly any forward-looking statement.
Contact:
Barrier Therapeutics, Inc.
Anne M. VanLent
609-945-1202
Noonan Russo
Jane Petrino
212-845-4274
"Sebazole is our second product candidate currently under active FDA review, following Vusion™, which is a significant milestone for Barrier," stated Geert Cauwenbergh, Ph.D., Chairman and CEO of Barrier Therapeutics, Inc. "If approved by the FDA, we believe Sebazole will provide significant patient benefits in the non-steroidal management of seborrheic dermatitis, with less risk for irritation and a more convenient treatment regimen as compared to currently available ketoconazole cream products."
The NDA submission for Sebazole was based on the results of a pivotal confirmatory Phase 3 clinical trial in addition to the results from two prior supportive Phase 3 trials. In the confirmatory two arm Phase 3 pivotal study, which enrolled 459 subjects at 24 centers across the United States, Sebazole achieved statistical significance at the primary endpoint as compared to the vehicle treated patients (p=0.001). The study was a double blind, vehicle-controlled study of once-a-day Sebazole treatment compared to the vehicle (the waterless gel formulation alone). Sebazole also achieved statistical significance for the same primary efficacy endpoint in both of the prior Phase 3 clinical trials, which enrolled a combined total of 474 patients in the Sebazole and vehicle arms at 47 centers in the United States and Europe (U.S. study: p < 0.001 and European study: p=0.021). The earlier two Phase 3 studies had four treatment arms (Sebazole, the vehicle alone, the vehicle containing a topical steroid known as desonide, and the combination of desonide with Sebazole). The primary efficacy endpoint for all three Phase 3 studies was the proportion of subjects who were effectively treated at day 28, which is 14 days following the end of a two-week treatment period.
The filing of an NDA with the FDA is an important step in the approval process in the United States. Acceptance for filing by the FDA does not mean that the NDA has been or will be approved, nor does it represent an evaluation of the adequacy of the data submitted.
About Seborrheic Dermatitis
Seborrheic dermatitis is a skin inflammation characterized by a red, scaly, itchy rash primarily occurring on the face, scalp, hairline, eyebrows and trunk. The condition often recurs, thereby requiring re-treatment over time. Seborrheic dermatitis affects approximately 3% to 5% of the U.S. population. Barrier Therapeutics estimates that approximately 8.5 to 14.3 million people in the U.S. are affected. Current prescription therapies consist primarily of topical ketoconazole creams and topical steroids. These treatments typically require multiple applications per day over periods of up to four weeks to be effective.
About Barrier Therapeutics, Inc.
Barrier Therapeutics, Inc. is a pharmaceutical company focused on the discovery, development and commercialization of pharmaceutical products in the field of dermatology. The Company currently markets Solagé® (mequinol 2%, tretinoin 0.01%) Topical Solution in the U.S. and Canada for the treatment of solar lentigines, a common condition also known as "age spots," and markets VANIQA®, (eflornithine hydrochloride) Cream 13.9% for slowing the growth of unwanted facial hair in women in Canada. Barrier has eight product candidates in various stages of clinical development. The four most advanced product candidates include Vusion™ (formerly known as Zimycan™) for the treatment of diaper dermatitis complicated by candidiasis, Sebazole™, for the treatment of seborrheic dermatitis, which are under FDA review, and two other product candidates in Phase 3 for the treatment of onychomycosis and congenital ichthyosis, respectively. Barrier has product candidates in earlier stages of clinical development for the treatment of acne, psoriasis and fungal infections. The Company is headquartered in Princeton, New Jersey and has wholly owned subsidiaries in Geel, Belgium and Ontario, Canada.
Web site: http://www.barriertherapeutics.com.
Safe Harbor Statement
In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of the "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding the potential patient benefits of Sebazole. Forward-looking statements provide Barrier's current expectations or forecasts of future events. Barrier's performance and financial results could differ materially from those reflected in these forward-looking statements due to decisions of regulatory authorities, patient and market acceptance of Sebazole, general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries generally. For a discussion of these and other risks and uncertainties that may effect the forward-looking statements, please see the risk factors in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2005 that is on file with the Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Barrier undertakes no obligation to update publicly any forward-looking statement.
Contact:
Barrier Therapeutics, Inc.
Anne M. VanLent
609-945-1202
Noonan Russo
Jane Petrino
212-845-4274
Saturday, December 17, 2005
Fungus Toenails? Maybe Not
Fungus infections cause less than five percent of deformed nails. Drying of skin and skin conditions such as psoriasis are more common causes.
The part of nails that you see is dead. Living nails are located underneath the skin at their base. It takes four and a half months for the nail to grow from the nail plate to its end where you cut it off. During this time, the nail dries out and the ends can crack and fray. So the most common cause of deformed nails is drying with aging, best treated by coating the nails with nail polish three times a week. The polish delays sublimation of water and helps to prevent drying.
Most deformed nails are caused by skin conditions such as psoriasis or seborrheic dermatitis. If you have thickened toenails, check with your doctor, a podiatrist or dermatologist who will clip off a piece of the nail and place it in a special bottle to culture it for a fungus.
Since a fungus infection in the nail starts in the plate underneath the skin and no creams can get into the nail plate, pills are the most effective treatment for toenail fungus infections. A special laquer called Penlac can cure some fungus nails when applied for several weeks. Fungus infections can be cured by 2 100 mg itraconazole pills each morning every other week for 4 to 5 months, or by another drug called terbinafine. If no fungus is present, fungus pills will not help. If no fungus is present, most effective treatment is to go to a medical supply store and buy surgical quality nail clippers. They are strong enough to cut thickened toenails without tearing them.
Dr. Gabe Mirkin has been a radio talk show host for 25 years and practicing physician for more than 40 years; he is board certified in four specialties, including sports medicine. Read or listen to hundreds of his fitness and health reports at http://www.DrMirkin.com
Free weekly newsletter on fitness, health and nutrition
The part of nails that you see is dead. Living nails are located underneath the skin at their base. It takes four and a half months for the nail to grow from the nail plate to its end where you cut it off. During this time, the nail dries out and the ends can crack and fray. So the most common cause of deformed nails is drying with aging, best treated by coating the nails with nail polish three times a week. The polish delays sublimation of water and helps to prevent drying.
Most deformed nails are caused by skin conditions such as psoriasis or seborrheic dermatitis. If you have thickened toenails, check with your doctor, a podiatrist or dermatologist who will clip off a piece of the nail and place it in a special bottle to culture it for a fungus.
Since a fungus infection in the nail starts in the plate underneath the skin and no creams can get into the nail plate, pills are the most effective treatment for toenail fungus infections. A special laquer called Penlac can cure some fungus nails when applied for several weeks. Fungus infections can be cured by 2 100 mg itraconazole pills each morning every other week for 4 to 5 months, or by another drug called terbinafine. If no fungus is present, fungus pills will not help. If no fungus is present, most effective treatment is to go to a medical supply store and buy surgical quality nail clippers. They are strong enough to cut thickened toenails without tearing them.
Dr. Gabe Mirkin has been a radio talk show host for 25 years and practicing physician for more than 40 years; he is board certified in four specialties, including sports medicine. Read or listen to hundreds of his fitness and health reports at http://www.DrMirkin.com
Free weekly newsletter on fitness, health and nutrition
