(RxWiki News) Fall means leaves changing colors, cooler weather and ragweed allergies. For allergy sufferers, a long-term treatment is being developed to ease ragweed allergy symptoms.
An allergy immunotherapy pill is being developed by Merck to provide long-term relief from ragweed allergies symptoms.
Immunotherapy works by exposing ragweed sufferers to a small dose of ragweed extract to affect how the immune system responds to the irritant. The pill is dissolved under the tongue making it easy to use for many ragweed allergy sufferers.
"Ask your doctor about ways to help manage raweed allergy symptoms. "
The Phase 3 double-blind clinical trial data was presented by Merck at the American Academy of Allergy, Asthma & Immunology annual meeting. The trial involved 565 ragweed allergy sufferers split into three groups, one group receiving a placebo, one receiving a lower dose immunotherapy pill and the other group receiving a higher dose immunotherapy pill.
The 565 participants suffered from hay fever due to ragweed and 85 percent had multiple allergies. Electronic diaries were used during the ragweed season to record allergy symptoms, medication usage and severity of symptoms. Any side effects were also recorded to determine safety.
The three groups were treated for a total of 52 weeks, starting 16 weeks before the start of ragweed season. The immunotherapy pill is used once daily. During peak ragweed season, the group using the lower dose ragweed immunotherapy pill showed a 21 percent improvement in allergy symptoms when compared to the group taking a placebo.
The higher dose group had a 27 percent improvement in symptoms when compared to the placebo group. Symptoms included watery eyes, runny nose, sneezing and congestion.
Medication usage was down for both immunotherapy pill groups when compared to the group taking a placebo. The lower dose group had a 41 percent improvement in medication usage while the higher dose group had a 45 percent improvement in medication usage.
Side effects included mouth itchiness as well as ear, mouth and throat irritation. Two participants had to receive epinephrine during the study, but the release did not indicate if the participants were part of the placebo group or one of the two immunotherapy groups.
Merck has partnered with ALK-Abello to develop allergy immunotherapy tablets (AITs) to treat these allergens in North America and plans to file New Drug Applications (NDAs) for its ragweed and grass AITs with the U.S. Food and Drug Administration (FDA) in 2013.
This study was presented at the annual meeting of the American Academy of Allergy, Asthma & Immunology. All results are considered preliminary until published in a peer-reviewed journal.