Emerging Therapies: Glycopyrronium Tosylate

Dee Anna Glaser, MD: We’ve talked about what we have right now, so let’s talk for a couple of minutes about what’s upcoming, emerging. The one that’s closest, or is soon to be ready, is glycopyrronium tosylate. This is a topical anticholinergic that has completed phase III trials and is in the FDA. This will be one that has been studied, not just one of the compounded products that I’m having mixed up and given to patients. I know it’s going to be indicated for axillary hyperhidrosis, right?

Adelaide Hebert, MD: That is correct. One of the exciting features of this new medication is that we studied it down to 9 years of age, so the pediatric patients were included. As a matter of fact, we only had 1 patient in all of the pediatric cohorts who dropped out because of anticholinergic side effects. It was very well tolerated down to 9 years of age. The product actually comes in a little towelette. You simply peel the outer packing off, pull the towelette out, wipe one axilla and then wipe the other axilla and then carefully wash your hands. I can’t emphasize that enough. That will reduce potential side effects from the medication getting to areas where it’s not anatomically intended to be used.

We really think that this is going to be a great advantage for our patients because they can do it at home. It hopefully will be covered by their pharmacy benefits. It will treat the axilla in a very effective way. We had excellent results in the clinical trial. We were one of the sites, and you had patients enrolled at your site as well. Patients really enjoyed using this medication and wanted to have the opportunity to use it in the future.

Dee Anna Glaser, MD: Yes. There really were no treatment-related problems. There were some patients who probably didn’t wash their hands well enough. They may have touched their eye in the middle of the night and experienced unilateral blurred vision. That was seen a few times. It was very well tolerated, topically, in terms of skin tolerability. We did not see the irritation that we’ve seen with some other therapies. There was really nice efficacy, good tolerability, and very good patient acceptance.

Adelaide Hebert, MD: Yes.

Dee Anna Glaser, MD: I’m excited about it. I am a person who has used a lot of compounded anticholinergic therapies, over the years, for my patients. It’s going to be nice to have something that is consistent. And I know exactly what’s in it. Sometimes I’m not sure what I’m getting. I don’t know if you have any comments on these compounding pharmacies and how consistent they are.

Andy Szczotka, PharmD: I think that’s a key point, in terms of the compound. We’re seeing a tick up in the use of compounding pharmacies, especially in this area with the anticholinergics. It would be nice to have something that’s going to be consistent in that process, to eliminate any potential variances between batches and between compounding areas, so the patients can get a predictable response. But we are seeing that tick up significantly.

Dee Anna Glaser, MD: Dermatologists are so particular about the vehicle that their medications are in. Sometimes I would have a compounding pharmacy just substitute a different type of vehicle. The delivery of the drug and the efficacy of the drug was a little bit different. So, this is a product that I wouldn’t be surprised to see out in the market in the very near future.

What are your thoughts on the towelette? It’s a whole new formulation.

Adelaide Hebert, MD: Absolutely. This was unique for us, as clinicians, and for our patients. It was a single-use towelette that was opened simply by tearing the packaging, removing the towelette, applying the towelette directly to one armpit, then applying the towelette to the other armpit. There was clearly enough medication to handle both anatomic areas. Then the patients were to replace the towelette back into the packaging, for the purpose of the study, and wash their hands comprehensively to remove any remaining medication that might have stayed on the hands after the application was completed.

Dee Anna Glaser, MD: Did any of the patients have problems if they didn’t wash their hands thoroughly after using the towelette?

Adelaide Hebert, MD: We did have a few patients who admitted to not following our instructions to the letter. They didn’t wash their hands as we had provided the guidance to do. But despite that, even if they had side effects, these were patients who absolutely were vocal about not being willing to leave the study because the improvement was so great. Despite that they had a side effect that they took ownership of, they wanted to remain in that study. They were vehement about it.

Dee Anna Glaser, MD: I think that’s a good point. There were 2 large studies that were done concurrently, and there were about 700 patients in each of those 2 studies. Multiple parameters were looked at. This included the new ASDD, or the Axillary Sweating Daily Diary, which is a validated scale that matches the FDA’s requirement for PROs (patient-reported outcomes). They were looking for at least a 4-point improvement.

Adelaide Hebert, MD: Yes.

Dee Anna Glaser, MD: And over 60% of patients in both of these trials achieved that endpoint. There was a reduction in the gravimetrics, in their sweat that was measured. There was an improvement in the Hyperhidrosis Disease Severity Scale, which is an older PRO scale that’s been used in numerous studies. And, in addition, there was a very high safety profile, from tolerability in the skin to very minor, mild, or moderate adverse events. We did have some patients who had unilateral blurred vision, which we assumed was from not washing their hands. I know we didn’t have any patients who had that twice.

Adelaide Hebert, MD: That’s right.

Dee Anna Glaser, MD: They knew that they had to start washing their hands more thoroughly. Our subjects really found this to be a very well-tolerated, very efficacious therapy. And this study extended for a year.

Adelaide Hebert, MD: Yes.

Dee Anna Glaser, MD: The original trial was 1 month. Then there was a long-term follow-up. So, we know that it works and we know that the results are sustainable. I think that’s what is making us all very excited about this new treatment.

I guess we still want to talk a little bit about what we need to do in the future, right?

Adelaide Hebert, MD: Yes. I think that this study was so impactful. In addition to things that you mentioned, the Dermatology Quality of Life indices and the Children’s Dermatology Life Quality indices also improved, in addition to the sweating that was perceived by the patient. So, we feel that this trial was very enlightening and very successful. It was very beneficial to the patients who participated. Many of the patients wanted to enroll into the long-term data component. Many of our patients stayed with us for this time and watching them be so successful in their overall management strategy was very rewarding. I also had patients who didn’t wash their hands 1 time. They learned from that experience and did not repeat that. And again, they wanted to stay in the study.