Asthma Inhaler Primatene Mist Going Off the Market

Over-the-counter asthma inhalers containing chloroflouorocarbons (CFCs), which can damage the ozone layer, will not be made or sold after Dec. 31, the U.S. Food and Drug Administration announced Thursday.

The sole product affected is Primatene Mist, marketed by Armstrong Pharmaceutical Inc., because it is the only inhaler approved by the FDA to be sold without a prescription for the relief of occasional symptoms of mild asthma.
"With this phase-out, all of the other inhalers that could substitute for the CFC over-the-counter inhaler to relieve symptoms of mild asthma require a prescription," Dr. Andrea Leonard-Segal, director of the FDA's Division of Nonprescription Clinical Evaluation, said during a morning news conference.
Primatene Mist uses CFCs to propel epinephrine from the inhaler so it can be taken into the lungs.
"Consumers who use Primatene Mist need to take action now to see a health-care provider to get a prescription for a replacement product," Leonard-Segal said. "Primatene Mist may be even harder to find on store shelves even before Dec. 31, 2011."
People who have the product after Dec. 31 can continue to take it as long as it hasn't expired, Leonard-Segal said.
The product is being removed from the market to comply with the Montreal Protocol on Substances that Deplete the Ozone Layer. This international agreement, signed by the United States, calls for phasing out chemicals that deplete the ozone layer, including CFCs.
Many manufacturers have replaced CFCs with an environmentally friendly propellant called hydrofluoroalkane (HFA). However, there are no HFA versions of over-the-counter epinephrine inhalers currently available, the FDA said.
While the other types of medications delivered through HFA inhalers are effective, there are some significant differences between HFA and CFC inhalers that people need to be aware of, Leonard-Segal said.
They include:

• Priming. When you first use an HFA inhaler, or if you haven't used it in awhile, you need to "prime" the pump to ensure that you're getting the accurate dose of medication. Priming entails spraying a dose or doses into the air, and priming requirements are different for each inhaler. Ask your pharmacist or check the package insert for your inhaler's priming requirements.
• Inhaling. The spray from HFA inhalers doesn't come out as forcefully, and some people have reported feeling as if they're not getting enough medication. For more detailed instructions on the proper technique for using an inhaler, ask your doctor or pharmacist, or check the package insert, which also has instructions for using the inhaler.
• Cleaning. HFA inhalers need to be cleaned more often than CFC inhalers.

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Potential New Hope And Treatment For Endometrial Cancer Released

Advanced endometrial cancer refers to several types of malignancies that arise from the endometrium, or lining, of the uterus. Endometrial cancers are the most common gynecologic cancers in the United States, with over 35,000 women diagnosed each year. However, in a new research, there may be progress to a single treatment solution called AEZS-108.

Overall, "tolerability" of AEZS-108 was good and commonly allowed retreatment as scheduled. Only one patient had a dose reduction, and less than 10% of treatment courses were postponed, including more than half of the cases in which the delay was not related to toxicity.

Good tolerability of AEZS-108 was also reflected by a low rate of severe non-hematological possibly drug-related adverse events which included single cases each of nausea, diarrhea, fatigue, general health deterioration, creatinine elevation, and blood potassium decrease. No cardiac toxicity was reported.

Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris comments:

"We would first like to thank Dr. Wimberger and all those involved in this trial for their dedicated work which is now being presented to the international gynecological community. We are very excited about these final results achieved with AEZS-108 alone, which compare favorably with those usually seen with more aggressive and less well tolerated combination regimens for endometrial cancer. On this basis, we have requested Parallel Scientific Advice from both the FDA and the EMA for the further pivotal development of AEZS-108 in this indication in the upcoming months."

The referred to Dr. Wimberger added:

"The safety and efficacy of AEZS-108 in our study on advanced endometrial cancer was very encouraging. Although used as a single agent treatment only, AEZS-108 achieved good response rates and disease stabilization. Personally, I was impressed to see three responses in the five patients treated at my institution, including one long-lasting complete response."

This year, the American Cancer Society estimates that more than 43,000 cases of endometrial cancer will be diagnosed in the United States. Symptoms can include unexplained vaginal bleeding, painful urination, painful intercourse and soreness in the pelvic area. There is no routine test to identify endometrial cancer.

Endometrial cancer may sometimes be referred to as uterine cancer. However, different cancers may develop not only from the endometrium itself but also from other tissues of the uterus, including cervical cancer, sarcoma of the myometrium, and trophoblastic disease.

Treatment options include surgery, radiation therapy, hormone therapy and chemotherapy; however, there are new treatments in development that work by targeting and destroying cancerous cells.

Basically, AEZS-108 represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. AEZS-108 is the first intravenous drug in a clinical study that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, resulting in more targeted treatment with less damage to healthy tissue.

Currently, the primary treatment is surgical. Surgical treatment should consist of, at least, cytologic sampling of the peritoneal fluid, abdominal exploration, palpation and biopsy of suspicious lymph nodes, abdominal hysterectomy, and removal of both ovaries (bilateral salpingo-oophorectomy).

Lymphadenectomy, or removal of pelvic and para-aortic lymph nodes, is sometimes performed for tumors that have high risk features, such as pathologic grade 3 serous or clear-cell tumors, invasion of more than 1/2 the myometrium, or extension to the cervix or adnexa. Sometimes, removal of the omentum is also performed.

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