Having a potential life threating allergy impacts a person’s life in many ways. One way is the medicine you use to treat your allergy and how it is administered. Now what if the Food and Drug Administration (FDA) approved a treatment that could make it easier to use, as in the case of dissolving epinephrine, or more convenient as in the case of at-home asthma injections, it could be game changer for allergy suffers as well as their friends and family. Read here about the efforts of two pharmaceuticals companies that are attempting to create these game changers.
An Oral Epinephrine ‘Film’ to Stop Allergic Reactions?
The hesitancy of some people to use an epinephrine auto-injector for anaphylaxis has led to a longstanding interest in developing an alternative that doesn’t involve a needle.
While efforts to develop an oral, sublingual epinephrine pill have yet to succeed, Aquestive Therapeutics, based in New Jersey, just launched a Phase 1 clinical trial of an epinephrine “film” that dissolves under the tongue. The trial, which will enroll up to 28 people, will compare the effectiveness of the film with epinephrine given by injection.
Teva Pharmaceuticals, one of the world’s largest makers of generic drugs, may soon be indicted by the U.S. Department of Justice. This most recent investigation by the DOJ focused on Teva and other drug companies conspiring to fix prices on several widely used generic medications.
DOJ preparing criminal antitrust complaint against drug-maker
U.S. prosecutors are preparing to charge Teva Pharmaceutical Industries Ltd. with conspiring with competitors to raise prices for generic drugs, according to a person familiar with the matter.
The Justice Department is planning to charge Teva as soon as Tuesday after the company rebuffed a settlement that would have required paying a criminal penalty and admitting wrongdoing, said the person, who declined to be named because the matter is confidential.
Teva’s U.S.-traded shares fell as much as 6% on the news and were down 2.3% to $9.41 at 3:25 p.m. in New York. A spokesperson for the company, which is based in Israel, declined to comment.
Charges against Teva, the world’s largest generic-drug maker by market value, would mark the most significant case to come out of the Justice Department’s years-long investigation into allegations that companies conspired with one another to prop up the prices of certain widely used medications. Nine of every 10 prescription drugs dispensed in the U.S. are generics.
In developing an adhesive patch treatment, DBV Technologies, believed they found an effective and safe method to provide help to those suffering from peanut allergies. The Food and Drug Administration didn’t agree. The FDA has decided not to approve, at least for now, DBV Technologies’ Viaskin Peanut, a skin patch allergy desensitization treatment. The FDA’s concern appears to be around the issue of adhesion to the skin and its possible impact on treatment. While the FDA’s decision was met with disappointment within the food allergy community and DBV, there continues to be hope that the needed changes can be made, that the FDA will be able to approve and that a new treatment for peanut allergy sufferers will be available.
The FDA says it won’t approve DBV Technologies’ Viaskin Peanut, the novel skin patch allergy desensitization treatment, at least not in its current form.
In announcing the drug regulator’s decision, DBV said in a press release that the FDA raised concerns about Viaskin patch’s adhesion to the skin and the impact of that on treatment. To address the concerns, DBV says the FDA calls for patch modifications, followed by “a new human factor study.”
The company’s leadership vows to comply with the FDA’s requests and move forward. “We are very disappointed in the FDA’s response, but continue to believe in the potential of Viaskin Peanut,” Daniel Tassé, CEO of DBV, said in the August 4 release.
DBV says the FDA also requested further clinical data on chemistry and manufacturing. No safety concerns were raised related to the therapy.
Doctor, researcher and parent of a child with food allergies, all three roles influence Ruchi Gupta, MD, MPH in her work as the founding Director of the Center for Food Allergy & Asthma Research (CFAAR) at Northwestern’s Institute for Public Health and Medicine (IPHAM). At CFAAR, she and her team conduct research investigating the causes behind food allergies as well as the possible influences that environment may play. Their work also goes beyond the laboratory. They have engaged the community by co-hosting over 100 “health leader” workshops. These workshops work towards empowering Chicago public high school students to become health advocates through educating their own peers and community members. Learn more about Dr. Gupta and the CFAAR’s vital work here.
Center for Food Allergy & Asthma Research Director Ruchi Gupta, MD, MPH, Leads with a Personal Touch
By Gina Bazer July 27th, 2020
A small comic strip displayed in the office of Ruchi Gupta, MD, MPH, serves as a sort of mission statement. The first frame shows an adult telling a child, “When I was your age, there were no food allergies.” The next one shows that same child, now grown up, telling a younger kid, “When I was your age, there were food allergies.”
Epinephrine is the known treatment for anaphylaxis. The way that epinephrine is administered is through injection. That may soon change. ARS Pharmaceuticals has announced that the United States Patent and Trademark Office issued a second key patent for ARS-1, a low dose intranasal epinephrine nasal spray currently in clinical development. Because time is of the essence when an anaphylaxis attack occurs, many believe, as does ASR, an epinephrine nasal spray can be an effective replacement treatment of autoinjectors. A fear of needles or apprehension of operating an auto-injector has been sighted as one of the reasons for the desire for an epinephrine nasal spray.
ARS Pharmaceuticals today announced that on June 16, 2020, the United States Patent and Trademark Office issued a second key patent for ARS-1, a low dose intranasal epinephrine nasal spray currently in clinical development. This dosage is significantly lower than other reported investigational intranasal epinephrine projects in development and thus helps protect against possible accidental overdose risk during a severe allergic reaction. This follows a patent approved last year covering the composition of matter of ARS-1. ARS Pharmaceuticals is dedicated to putting patients first and these ARS-1 innovations are an important step for those with severe allergic reactions to get lifesaving, pain free treatment.