FDA gives approval to Impavido
SILVER SPRING, Md. — The Food and Drug Administration announced the approval of Impavido (miltefosine) to treat a tropical disease called leishmaniasis. Leishmaniasis is caused by Leishmania, a parasite transmitted to humans through sand fly bites. It’s the first FDA-approved drug to treat cutaneous or mucosal leishmaniasis.
Impavido is an oral medication approved to treat the three main types of leishmaniasis: visceral leishmaniasis, which affects internal organs; cutaneous leishmaniasis, which affects the skin; and mucosal leishmaniasis, which affects the nose and throat. It’s intended for patients ages 12 years or older.
The disease is prevalent in people who live in the tropics or subtropics; most U.S. patients acquire the disease overseas, the agency said.
“Today’s approval demonstrates the FDA’s commitment to making available therapeutic options to treat tropical diseases,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
The labeling for Impavido includes a boxed warning alerting patients and healthcare professionals that the drug can cause fetal harm and shouldn’t be given to pregnant women. Healthcare professionals should advise women to use effective contraception during and for five months after Impavido therapy, the agency noted. Common side effects identified in clinical trials were nausea, vomiting, diarrhea, headache, decreased appetite, dizziness, abdominal pain, itching, drowsiness and elevated liver enzymes (transaminases) and creatinine.
Impavido is manufactured by Paladin Therapeutics, which is based in Montreal, Canada.
Purdue Pharma to file NDA for abuse deterrent formulation of hydrocodone bitartrate
STAMFORD, Conn. — Purdue Pharma recently announced that a Phase 3 study of an investigational extended‐release formulation of hydrocodone bitartrate met its primary efficacy endpoint by showing that patients with chronic low back pain treated with the once‐daily analgesic agent experienced statistically significant reduction in pain compared with placebo.
This investigational single‐entity opioid analgesic formulation incorporates abuse deterrent properties intended to make the tablets more difficult to manipulate for the purpose of misuse and abuse by various routes of administration (e.g., snorting and intravenous injection).
“We are very encouraged by the results of this pivotal study,” stated Gary Stiles, Purdue Pharma SVP research and development. “This is another step forward in our efforts to develop therapeutic options for use by chronic pain patients that are designed to be unattractive to drug seekers.”
In the study, the majority of patients treated with hydrocodone bitartrate dosed once‐daily experienced at least a 30% improvement in pain intensity. Nearly half of patients (48%) achieved a 50% improvement with hydrocodone bitartrate.
In addition to this safety and efficacy study, Purdue Pharma has conducted a series of laboratory manipulation and extraction studies, pharmacokinetic studies and clinical abuse potential studies with this investigational medication. The company plans to file a New Drug Application with the FDA later in 2014 requesting approval to market the medication.
Currently available hydrocodone formulations do not incorporate abuse‐deterrent technologies, Purdue Pharma noted.
P&G introduces Febreze allergen reducer, partners with Sam Champion
CINCINNATI — Procter & Gamble on Thursday announced that its brand Febreze has partnered with the Weather Channel’s newest anchor Sam Champion, host of “America’s Morning Headquarters with Sam Champion,” to educate consumers on the connection between the outdoor pollen count and allergens found in the home. Champion will help introduce Febreze Fabric Refresher Allergen Reducer, a new product that eliminates odors and reduces up to 95% of inanimate allergens from pollen, pet dander and dust mite matter that can become airborne from fabrics after making their way into the home.
“The outdoor pollen cast and allergy index are a critical portion of the weather forecast, but what people may not know is how the outdoor report can affect the indoors,” Champion said. “Weather can affect the allergen count in your home, so I’m thrilled to partner with Febreze to educate consumers on this important connection and on the new Febreze Fabric Refresher Allergen Reducer that will help Americans this spring season.”
Fabric and upholstered furniture, like couches, curtains and carpets, can often act as a reservoir for allergens, particularly during the spring and fall when pollen can be carried into the home by family members, guests and pets. When you sit on the couch, walk on the carpet or fluff up the pillows, you often release the allergens that have settled onto the fabric into the air you breathe. Febreze Allergen Reducer features a unique technology that acts as a net that flexes over allergen particles, trapping them on the fabric until they can be removed through routine cleaning and vacuuming.
“While it’s easy to wash the allergens that can accumulate on your clothing, it’s hard to tackle the daily allergens from pollen, pet dander and dust mites that become airborne in the home from tough-to-wash fabrics,” said Kirsten McKillop, Febreze principal scientist. “Febreze Fabric Refresher Allergen Reducer was developed to address this issue, to help consumers achieve a deeper clean, particularly when pollen counts are high.”
Febreze Allergen Reducer is available in both Fabric Refresher and Air Effects. Febreze Fabric Refresher Allergen Reducer comes in Unscented and Clean Splash. Febreze Air Effects Allergen Reducer is available in three light scents, Clean Splash, Freshly Clean and Soft & Light. The suggested retail price for Febreze Air Effects Allergen Reducer (9.7 oz) and Febreze Fabric Refresher Allergen Reducer (500ml) is $4.29, and $6.29 for Fabric Refresher (800ml).