FDA Approvals & News
New Non-Invasive Wrinkle Treatment Applicator from Syneron
Syneron Medical Ltd. announced that the FDA granted a 510(k) marketing clearance to Syneron’s new ST applicator for non-invasive wrinkle treatment.
Using the ST applicator, the ReFirme procedure offers patients a non-invasive, less painful alternative for skin tightening and wrinkle reduction on the neck, face and other areas. The ReFirme treatment with the ST applicator uses a pulse repetition rate of one pulse per second and uses Syneron’s elôs (electro-optical synergy) technology. The lower energy level needed to power the ReFirm allows patients to be treated with less pain than is typically associated with skin tightening and wrinkle improvement treatments.
The new ST applicator works with both the new eLight and the eMax platforms. Both platforms combine electrical energy (bi-polar radio frequency) and optical energy to enable efficient and safe treatments for patients.
The ST applicator expands the broad range of functions of these two recently launched platforms. The eLight is Syneron’s new complete elôs facial treatment system. In addition to now treating wrinkles using the ST applicator, the eLight can also be used to treat vascular and pigmented lesions and acne conditions with additional applicators. The eMax is the complete elôs workstation, covering all of the capabilities of the eLight and providing high-speed, laser-based hair removal and treatment for leg veins.
Atopic Dermatitis Treatment
SkinMedica announced positive outcomes of two Phase III clinical trials evaluating desonide (Desonate HydroGel 0.05%), a low-potency topical steroid formulated in a proprietary alcohol-free, aqueous gel delivery vehicle, to treat atopic dermatitis.
The clinical trials were conducted as a multi-center, randomized, double-blind, placebo-controlled comparison involving pediatric patients with mild to moderate atopic dermatitis. For these trials, 585 patients aged 3 months to 18 years were treated with either the Desonate HydroGel or placebo twice daily for 4 weeks.
Primary endpoints included Investigator Global Severity Assessment (IGSA) along with alleviation of signs and symptoms of atopic dermatitis, including erythema, induration/papulation and scaling. The proportion of patients achieving treatment success using the IGSA primary end-point was 44% for the Desonate group and 14% for the vehicle group in the first trial. In the second trial, treatment success rates were 28% for the Desonate group and 6% for the vehicle group.
The studies also showed that Desonate was well tolerated. Most side effects were mild and limited to application site reactions. There were no serious adverse events reported.
Lice Drug Approved for Phase III Trial
Piedmont Pharmaceuticals has received approval from the FDA to begin a Phase III trial of its head lice treatment drug known as Resultz. The trial will test the drug’s safety and efficacy, which have already been demonstrated in Phase I and II trials, on a wider population.
Resultz is a noninsecticide-based drug that is different from the major head lice treatments currently available, which are generally based on active ingredients lindane or malathion. These ingredients are effective, but human safety concerns about the drugs have led the FDA to require a boxed warning on products containing such ingredients.
Relief for Severe Dermatitis
Patients suffering with severe persistent dermatitis who fail to respond to standard treatments may find relief with the addition of omalizumab (Xolair), according to Dr. Joshua E. Lane and colleagues at Dermatologic Surgery Specialists of Macon. The researchers, who published their study in the Journal of the American Academy of Dermatology, used Xolair to treat three patients aged 10 to 13 years with severe refractory dermatitis and IgE levels ranging from 1990 to 6120 IU/mL.
All three patients had failed to improve with conventional therapies, including topical and oral steroids, oral antibiotics, antihistamines, and other more potent agents. All three patients improved with treatment with Xolair in combination with some of these other therapies.
Xolair is currently approved to treat
asthma in patients 12 year of age and older who have IgE levels up to 700 IU/mL. Xolair, a laboratory-generated monoclonal antibody that is given by injection, is designed to bind to IgE, a naturally occurring antibody, and prevent it from triggering the release of chemicals that cause asthma and allergy attacks.
S&A News & Trends
On The Road to Skin Cancer Detection
In an effort to raise public awareness about skin cancer and the importance of early detection and treatment, Doak Dermatologics, a subsidiary of Bradley Pharmaceuticals, Inc., and The Skin Cancer Foundation are joining forces in a cross-country tour. Using a custom-designed Mobile Diagnosis Vehicle (MDv), the tour will be heading to cities throughout the United States to conduct screenings and educate the public about the dangers of actinic keratosis, squamous cell carcinoma, basal cell carcinoma and melanoma.
The MDv is a self-sufficient RV, so no connection to power outlets are required. The RV is scheduled to travel to various cities around the country from March through October. Patients can stop by the RV any time during screening hours to fill out a questionnaire, receive educational materials and have their skin screened for free.
To find out more about this program and for a detailed itinerary, visit
www.skincancerscreeningtour.com.
In Brief...
Ipsen and Medicis Announced… that Ipsen Ltd, a wholly-owned subsidiary of Ipsen, has granted Aesthetica Ltd, a wholly-owned subsidiary of Medicis, rights to develop, distribute and commercialize Ipsen’s botulinum toxin product in the United States, Canada and Japan. The product is commonly referred to as Reloxin in the United States and Dysport for medical and aesthetic markets outside the United States. The product is not currently approved for use in the United States.
Allergan Inc., Announced… that it has completed its acquisition of Inamed Corp. The acquisition of Inamed expands Allergan’s global position as a specialty pharmaceutical and medical device company in high-growth markets, such as dermatology.
The National Rosacea Society Designated…April as Rosacea Awarenenss Month to alert the public to the warning signs of this condition. During April, extensive public education activities will be conducted to increase awareness and understanding of rosacea, emphasizing its warning signs and urging those who suspect they may have rosacea to see a dermatologist. Patients can call (888) NO-BLUSH for more information.
DUSA Pharmaceuticals Announced…that it has closed the acquisition of Sirius Laboratories Inc., into a subsidiary of DUSA. Sirius is a privately-held dermatology specialty pharmaceutical company with a primary focus on the treatment of acne
vulgaris and acne rosacea.
FDA Approvals & News
New Non-Invasive Wrinkle Treatment Applicator from Syneron
Syneron Medical Ltd. announced that the FDA granted a 510(k) marketing clearance to Syneron’s new ST applicator for non-invasive wrinkle treatment.
Using the ST applicator, the ReFirme procedure offers patients a non-invasive, less painful alternative for skin tightening and wrinkle reduction on the neck, face and other areas. The ReFirme treatment with the ST applicator uses a pulse repetition rate of one pulse per second and uses Syneron’s elôs (electro-optical synergy) technology. The lower energy level needed to power the ReFirm allows patients to be treated with less pain than is typically associated with skin tightening and wrinkle improvement treatments.
The new ST applicator works with both the new eLight and the eMax platforms. Both platforms combine electrical energy (bi-polar radio frequency) and optical energy to enable efficient and safe treatments for patients.
The ST applicator expands the broad range of functions of these two recently launched platforms. The eLight is Syneron’s new complete elôs facial treatment system. In addition to now treating wrinkles using the ST applicator, the eLight can also be used to treat vascular and pigmented lesions and acne conditions with additional applicators. The eMax is the complete elôs workstation, covering all of the capabilities of the eLight and providing high-speed, laser-based hair removal and treatment for leg veins.
Atopic Dermatitis Treatment
SkinMedica announced positive outcomes of two Phase III clinical trials evaluating desonide (Desonate HydroGel 0.05%), a low-potency topical steroid formulated in a proprietary alcohol-free, aqueous gel delivery vehicle, to treat atopic dermatitis.
The clinical trials were conducted as a multi-center, randomized, double-blind, placebo-controlled comparison involving pediatric patients with mild to moderate atopic dermatitis. For these trials, 585 patients aged 3 months to 18 years were treated with either the Desonate HydroGel or placebo twice daily for 4 weeks.
Primary endpoints included Investigator Global Severity Assessment (IGSA) along with alleviation of signs and symptoms of atopic dermatitis, including erythema, induration/papulation and scaling. The proportion of patients achieving treatment success using the IGSA primary end-point was 44% for the Desonate group and 14% for the vehicle group in the first trial. In the second trial, treatment success rates were 28% for the Desonate group and 6% for the vehicle group.
The studies also showed that Desonate was well tolerated. Most side effects were mild and limited to application site reactions. There were no serious adverse events reported.
Lice Drug Approved for Phase III Trial
Piedmont Pharmaceuticals has received approval from the FDA to begin a Phase III trial of its head lice treatment drug known as Resultz. The trial will test the drug’s safety and efficacy, which have already been demonstrated in Phase I and II trials, on a wider population.
Resultz is a noninsecticide-based drug that is different from the major head lice treatments currently available, which are generally based on active ingredients lindane or malathion. These ingredients are effective, but human safety concerns about the drugs have led the FDA to require a boxed warning on products containing such ingredients.
Relief for Severe Dermatitis
Patients suffering with severe persistent dermatitis who fail to respond to standard treatments may find relief with the addition of omalizumab (Xolair), according to Dr. Joshua E. Lane and colleagues at Dermatologic Surgery Specialists of Macon. The researchers, who published their study in the Journal of the American Academy of Dermatology, used Xolair to treat three patients aged 10 to 13 years with severe refractory dermatitis and IgE levels ranging from 1990 to 6120 IU/mL.
All three patients had failed to improve with conventional therapies, including topical and oral steroids, oral antibiotics, antihistamines, and other more potent agents. All three patients improved with treatment with Xolair in combination with some of these other therapies.
Xolair is currently approved to treat
asthma in patients 12 year of age and older who have IgE levels up to 700 IU/mL. Xolair, a laboratory-generated monoclonal antibody that is given by injection, is designed to bind to IgE, a naturally occurring antibody, and prevent it from triggering the release of chemicals that cause asthma and allergy attacks.
S&A News & Trends
On The Road to Skin Cancer Detection
In an effort to raise public awareness about skin cancer and the importance of early detection and treatment, Doak Dermatologics, a subsidiary of Bradley Pharmaceuticals, Inc., and The Skin Cancer Foundation are joining forces in a cross-country tour. Using a custom-designed Mobile Diagnosis Vehicle (MDv), the tour will be heading to cities throughout the United States to conduct screenings and educate the public about the dangers of actinic keratosis, squamous cell carcinoma, basal cell carcinoma and melanoma.
The MDv is a self-sufficient RV, so no connection to power outlets are required. The RV is scheduled to travel to various cities around the country from March through October. Patients can stop by the RV any time during screening hours to fill out a questionnaire, receive educational materials and have their skin screened for free.
To find out more about this program and for a detailed itinerary, visit
www.skincancerscreeningtour.com.
In Brief...
Ipsen and Medicis Announced… that Ipsen Ltd, a wholly-owned subsidiary of Ipsen, has granted Aesthetica Ltd, a wholly-owned subsidiary of Medicis, rights to develop, distribute and commercialize Ipsen’s botulinum toxin product in the United States, Canada and Japan. The product is commonly referred to as Reloxin in the United States and Dysport for medical and aesthetic markets outside the United States. The product is not currently approved for use in the United States.
Allergan Inc., Announced… that it has completed its acquisition of Inamed Corp. The acquisition of Inamed expands Allergan’s global position as a specialty pharmaceutical and medical device company in high-growth markets, such as dermatology.
The National Rosacea Society Designated…April as Rosacea Awarenenss Month to alert the public to the warning signs of this condition. During April, extensive public education activities will be conducted to increase awareness and understanding of rosacea, emphasizing its warning signs and urging those who suspect they may have rosacea to see a dermatologist. Patients can call (888) NO-BLUSH for more information.
DUSA Pharmaceuticals Announced…that it has closed the acquisition of Sirius Laboratories Inc., into a subsidiary of DUSA. Sirius is a privately-held dermatology specialty pharmaceutical company with a primary focus on the treatment of acne
vulgaris and acne rosacea.
FDA Approvals & News
New Non-Invasive Wrinkle Treatment Applicator from Syneron
Syneron Medical Ltd. announced that the FDA granted a 510(k) marketing clearance to Syneron’s new ST applicator for non-invasive wrinkle treatment.
Using the ST applicator, the ReFirme procedure offers patients a non-invasive, less painful alternative for skin tightening and wrinkle reduction on the neck, face and other areas. The ReFirme treatment with the ST applicator uses a pulse repetition rate of one pulse per second and uses Syneron’s elôs (electro-optical synergy) technology. The lower energy level needed to power the ReFirm allows patients to be treated with less pain than is typically associated with skin tightening and wrinkle improvement treatments.
The new ST applicator works with both the new eLight and the eMax platforms. Both platforms combine electrical energy (bi-polar radio frequency) and optical energy to enable efficient and safe treatments for patients.
The ST applicator expands the broad range of functions of these two recently launched platforms. The eLight is Syneron’s new complete elôs facial treatment system. In addition to now treating wrinkles using the ST applicator, the eLight can also be used to treat vascular and pigmented lesions and acne conditions with additional applicators. The eMax is the complete elôs workstation, covering all of the capabilities of the eLight and providing high-speed, laser-based hair removal and treatment for leg veins.
Atopic Dermatitis Treatment
SkinMedica announced positive outcomes of two Phase III clinical trials evaluating desonide (Desonate HydroGel 0.05%), a low-potency topical steroid formulated in a proprietary alcohol-free, aqueous gel delivery vehicle, to treat atopic dermatitis.
The clinical trials were conducted as a multi-center, randomized, double-blind, placebo-controlled comparison involving pediatric patients with mild to moderate atopic dermatitis. For these trials, 585 patients aged 3 months to 18 years were treated with either the Desonate HydroGel or placebo twice daily for 4 weeks.
Primary endpoints included Investigator Global Severity Assessment (IGSA) along with alleviation of signs and symptoms of atopic dermatitis, including erythema, induration/papulation and scaling. The proportion of patients achieving treatment success using the IGSA primary end-point was 44% for the Desonate group and 14% for the vehicle group in the first trial. In the second trial, treatment success rates were 28% for the Desonate group and 6% for the vehicle group.
The studies also showed that Desonate was well tolerated. Most side effects were mild and limited to application site reactions. There were no serious adverse events reported.
Lice Drug Approved for Phase III Trial
Piedmont Pharmaceuticals has received approval from the FDA to begin a Phase III trial of its head lice treatment drug known as Resultz. The trial will test the drug’s safety and efficacy, which have already been demonstrated in Phase I and II trials, on a wider population.
Resultz is a noninsecticide-based drug that is different from the major head lice treatments currently available, which are generally based on active ingredients lindane or malathion. These ingredients are effective, but human safety concerns about the drugs have led the FDA to require a boxed warning on products containing such ingredients.
Relief for Severe Dermatitis
Patients suffering with severe persistent dermatitis who fail to respond to standard treatments may find relief with the addition of omalizumab (Xolair), according to Dr. Joshua E. Lane and colleagues at Dermatologic Surgery Specialists of Macon. The researchers, who published their study in the Journal of the American Academy of Dermatology, used Xolair to treat three patients aged 10 to 13 years with severe refractory dermatitis and IgE levels ranging from 1990 to 6120 IU/mL.
All three patients had failed to improve with conventional therapies, including topical and oral steroids, oral antibiotics, antihistamines, and other more potent agents. All three patients improved with treatment with Xolair in combination with some of these other therapies.
Xolair is currently approved to treat
asthma in patients 12 year of age and older who have IgE levels up to 700 IU/mL. Xolair, a laboratory-generated monoclonal antibody that is given by injection, is designed to bind to IgE, a naturally occurring antibody, and prevent it from triggering the release of chemicals that cause asthma and allergy attacks.
S&A News & Trends
On The Road to Skin Cancer Detection
In an effort to raise public awareness about skin cancer and the importance of early detection and treatment, Doak Dermatologics, a subsidiary of Bradley Pharmaceuticals, Inc., and The Skin Cancer Foundation are joining forces in a cross-country tour. Using a custom-designed Mobile Diagnosis Vehicle (MDv), the tour will be heading to cities throughout the United States to conduct screenings and educate the public about the dangers of actinic keratosis, squamous cell carcinoma, basal cell carcinoma and melanoma.
The MDv is a self-sufficient RV, so no connection to power outlets are required. The RV is scheduled to travel to various cities around the country from March through October. Patients can stop by the RV any time during screening hours to fill out a questionnaire, receive educational materials and have their skin screened for free.
To find out more about this program and for a detailed itinerary, visit
www.skincancerscreeningtour.com.
In Brief...
Ipsen and Medicis Announced… that Ipsen Ltd, a wholly-owned subsidiary of Ipsen, has granted Aesthetica Ltd, a wholly-owned subsidiary of Medicis, rights to develop, distribute and commercialize Ipsen’s botulinum toxin product in the United States, Canada and Japan. The product is commonly referred to as Reloxin in the United States and Dysport for medical and aesthetic markets outside the United States. The product is not currently approved for use in the United States.
Allergan Inc., Announced… that it has completed its acquisition of Inamed Corp. The acquisition of Inamed expands Allergan’s global position as a specialty pharmaceutical and medical device company in high-growth markets, such as dermatology.
The National Rosacea Society Designated…April as Rosacea Awarenenss Month to alert the public to the warning signs of this condition. During April, extensive public education activities will be conducted to increase awareness and understanding of rosacea, emphasizing its warning signs and urging those who suspect they may have rosacea to see a dermatologist. Patients can call (888) NO-BLUSH for more information.
DUSA Pharmaceuticals Announced…that it has closed the acquisition of Sirius Laboratories Inc., into a subsidiary of DUSA. Sirius is a privately-held dermatology specialty pharmaceutical company with a primary focus on the treatment of acne
vulgaris and acne rosacea.
