Verrica Pharmaceuticals · VP-102 · Jun 2022 – Jul 2023
How did VP-102 get from a third FDA letter to approval in July 2023?
A Type A meeting in June 2022, a new bulk-solution manufacturer in Pennsylvania, a resubmission planned for early 2023, and approval on July 21, 2023. The 10-K that reports the approval names neither manufacturer.
EphemerisX Research · Published · 4 source documents · 2 min read
Short answer
After the May 2022 letter Verrica reported a Type A meeting at which, it says, the FDA confirmed the application had been fully reviewed with no other deficiencies, and it began working with Piramal Pharma Solutions to make the bulk solution. It planned to resubmit in the first quarter of 2023. The 2026 10-K records approval on July 21, 2023.
What the evidence shows
The September 2022 presentation: The FDA confirmed in a Type A meeting on June 27, 2022 that the NDA for VP-102 for molluscum contagiosum was fully reviewed and there were no other deficiencies in the NDA
8-K · Sep 14, 2022.
The August 2022 quarterly report: Verrica has begun working with Piramal Pharma Solutions to manufacture bulk solution for VP-102 at their Sellersville, Pennsylvania site.
8-K · Aug 11, 2022 At the Type A meeting, it says, the FDA indicated a willingness to work collaboratively on the amount of stability data required from an alternative CMO for the bulk solution of VP-102 at the time of resubmission as well as options for post-approval use of bulk solution previously manufactured
8-K · Aug 11, 2022.
A year earlier, Verrica's presentation had listed Limited commercial CMOs with facilities for handling highly potent and highly flammable liquid products
8-K · Sep 29, 2021.
The timing, as the chief executive put it: Based on the feedback from the FDA and the timing of the technology transfer to Piramal, we expect to be able to resubmit the NDA
8-K · Aug 11, 2022 in the first quarter of 2023. The resubmission would seek conditional approval to market VP-102 in the United States under the brand name YCANTH
8-K · Aug 11, 2022.
The 10-K: On July 21, 2023, YCANTH (VP-102) (cantharidin) 0.7% topical solution was the first product approved by the FDA for the treatment of molluscum
10-K · Mar 11, 2026, and We commercially launched YCANTH (VP-102) in August 2023
10-K · Mar 11, 2026. On manufacturing today: Our drug product contract manufacturers and primary packaging vendor are all US-based, FDA-registered establishments
10-K · Mar 11, 2026. The 2026 10-K names neither Sterling nor Piramal, and does not mention human factors, a Type A meeting or a CRL. 10-K · searched
This record follows the application to approval through the 10-K; the 2023 resubmission and the FDA's approval letter are not among its documents.
Follow the thread
- Why did the FDA's second letter turn on a contract manufacturer's facility?“Limited commercial CMOs”
- What changed between Verrica's second and third FDA letters?Sterling made the bulk solution
- What is the securities class action against Verrica about?The 10-K names neither manufacturer
- What happened to the glass ampule the FDA flagged in 2020?Approved July 21, 2023
This investigation connects to
- What happens after a second FDA Complete Response Letter?Cross-investigation · Divergent outcome · with Aldeyra Therapeutics, CorMedix, Outlook Therapeutics, Replimune
- What happens when an FDA letter turns on a contract manufacturer, not the drug?Cross-investigation · Shared concern · with CorMedix
The documents, by date
The passages quoted
Verrica Pharmaceuticals Form 8-K, filed September 29, 2021
Limited commercial CMOs with facilities for handling highly potent and highly flammable liquid productsOpen at the source →
Verrica Pharmaceuticals Form 8-K, filed August 11, 2022
Verrica expects to resubmit the NDA for VP-102 for the treatment of molluscum in the first quarter of 2023 and in its resubmission will seek conditional approval to market VP-102 in the United States under the brand name YCANTHOpen at the source →
Verrica Pharmaceuticals Form 8-K, filed August 11, 2022
Verrica has begun working with Piramal Pharma Solutions to manufacture bulk solution for VP-102 at their Sellersville, Pennsylvania site. Verrica will continue to work closely with Piramal and the FDA to facilitate a timely technology transfer and production quality at the facility.Open at the source →
Verrica Pharmaceuticals Form 8-K, filed August 11, 2022
Based on the feedback from the FDA and the timing of the technology transfer to Piramal, we expect to be able to resubmit the NDA for VP-102 for the treatment of molluscum contagiosum (molluscum) in the first quarter of 2023.”Open at the source →
Verrica Pharmaceuticals Form 8-K, filed August 11, 2022
Verrica announced that it held a Type A Meeting with the FDA regarding the path forward for the resubmission and potential approval of the NDA for VP-102 for the treatment of molluscum. The FDA indicated a willingness to work collaboratively on the amount of stability data required from an alternative CMO for the bulk solution of VP-102 at the time of resubmission as well as options for post-approval use of bulk solution previously manufactured.Open at the source →
Verrica Pharmaceuticals Form 8-K, filed September 14, 2022
Verrica received a Complete Response Letter (CRL) from the FDA in May 2022 as a direct result of deficiencies identified at a general reinspection of a facility of Sterling Pharmaceuticals Services, LLC (Sterling) a contract manufacturing organization (CMO) that manufactured the bulk solution for VP-102. None of the issues identified by the FDA during the reinspection were specific to the manufacturing of VP-102; a pre-approval inspection (PAI) was also conducted on VP-102 at Sterling with no observations. The FDA confirmed in a Type A meeting on June 27, 2022 that the NDA for VP-102 for molluscum contagiosum was fully reviewed and there were no other deficiencies in the NDA; label comments were completed by the FDA and were ready to be communicated.Open at the source →
Verrica Pharmaceuticals Form 10-K, filed March 11, 2026
The 2026 10-K names neither Sterling nor Piramal, and does not mention human factors, a Type A meeting or a CRL.
Open the document →Verrica Pharmaceuticals Form 10-K, filed March 11, 2026
On July 21, 2023, YCANTH (VP-102) (cantharidin) 0.7% topical solution was the first product approved by the FDA for the treatment of molluscum in adult and pediatric patients two years of age and older. We commercially launched YCANTH (VP-102) in August 2023 in the United States for the treatment of molluscum.Open at the source →
Verrica Pharmaceuticals Form 10-K, filed March 11, 2026
Our drug product contract manufacturers and primary packaging vendor are all US-based, FDA-registered establishments and have a history of supplying products to the pharmaceutical industry.Open at the source →