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Undeterred by the FDA’s rejection of its orally soluble film form of tadalafil, Aquestive Therapeutics has joined with IntelGenx Corporation to work together on a response to the drug regulatory agency. Currently, Staxyn is the only ED medication that’s designed to be taken without water.
A novel approach to delivering erectile dysfunction relief via an orally soluble film may be down, but it’s not yet out.
Late in 2018, New Jersey-based Aquestive Therapeutics received a complete response letter from the Food and Drug Administration rejecting Aquestive’s new drug application for an orally soluble film containing tadalafil. Tadalafil is the active ingredient in Cialis, prescribed to treat ED, and in Adcirca, United Therapeutics’ brand-name medication for the treatment of pulmonary arterial hypertension, a form of high blood pressure that targets the lungs.
FDA Cites Shortcomings
FDA’s complete response letter to Aquestive laid out in detail the shortcomings it had found in the company’s proposed product, which is currently code-named AQST-119. That gives the company what amounts to a roadmap that can be followed to remedy the drug’s deficiencies before resubmission of the proposed drug for approval.
One of the more memorable cases of an FDA complete response letter in recent memory was the letter sent to Sprout Pharmaceuticals after the drug regulatory agency rejected Addyi on the basis of incomplete testing data. Addyi, a drug developed to treat hypoactive sexual desire disorder, the most common form of female sexual dysfunction, was eventually approved by the FDA, but only after Sprout had followed the agency’s suggestions for further work on the drug.
Additional Test Data Sought
In its complete response letter to Aquestive, the FDA requested specific additional data from healthy volunteers on whom the drug had been tested. The company responded to this demand for added data by characterizing the FDA’s requests as “manageable.” Keith J. Kendall, Aquestive’s CEO, said that the company would “work with the FDA to map out our path to resubmission and approval.”
In May 2019 Aquestive announced that it had entered into a worldwide collaboration agreement with IntelGenx Corporation, a leading oral drug delivery company headquartered in suburban Montreal, Quebec. The companies’ agreement calls specifically for them to work together to co-develop and commercialize oral films containing tadalafil for the treatment of ED.
Project Remains Active
This seems to be a clear signal that Aquestive intends to forge ahead with its tadalafil oral film project, partnering with IntelGenx to attain that goal. In fact, the Aquestive-IntexGenx accord calls specifically for the companies to work together in formulating a response to the FDA’s CRL.
At the time that the Aquestive-IntelGenx agreement was announced, Dan Barber, Aquestive’s chief operating officer, said: “IntelGenx is a natural partner for our tadalafil oral film program.”
While no orally soluble form of tadalafil or Cialis is currently available on the market, men who have difficulty swallowing tablets or capsules can turn to compounding pharmacies who can convert the active ingredients into a form that’s easier to take. Needless to say, this increases the overall cost of the medication in question, but it does make the drug available to those who might otherwise be unable to take it.
Ordering ED Drugs Online
If swallowing pills is not a problem for you, you might find that you can save both time and money by ordering your ED drugs online from eDrugstore.com. A longtime online prescription drug service, eDrugstore is based in Tempe, Arizona, and offers convenience and added-value services that might very well make it the best choice for you.
If you order online from eDrugstore, you won’t have to worry about bothersome travel to and from the pharmacy nor wasting time for your prescription to be filled.
Ordering Viagra, Cialis, or any of the other popular ED medications requires a prescription. If you’re finding it difficult to fit a doctor’s visit into your schedule, eDrugstore can set up a complimentary online consultation with a licensed U.S. physician who can authorize a prescription if appropriate. To learn more, visit eDrugstore’s Erectile Dysfunction page.
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