Verrica Pharmaceuticals · VP-102 · Jul – Aug 2020
How did Verrica describe the FDA's first letter?
“No Clinical Safety or Efficacy Issues Identified,” said the press release. The letter's human factors section says the FDA remained concerned the product “is not safe for use by HCPs.”
EphemerisX Research · Published · 4 source documents · 1 min read
Short answer
Verrica's July 2020 release said the letter asked for more chemistry, manufacturing and controls (CMC) and human factors information, and identified no clinical safety or efficacy issues. The letter's human factors section, which is about the risk of accidental exposure in use, says the FDA remained concerned that the product is not safe for use by health care providers.
What the evidence shows
The release's headline: Complete Response Letter Requests Additional Chemistry, Manufacturing, and Controls (CMC) and Human Factors Information
8-K · Jul 14, 2020, and No Clinical Safety or Efficacy Issues Identified
8-K · Jul 14, 2020. Its text: the FDA is seeking additional information regarding certain aspects of the CMC (Chemistry, Manufacturing, and Controls) process for the drug/device combination, as well as Human Factors validation
8-K · Jul 14, 2020. Importantly, the FDA did not identify any clinical deficiencies.
8-K · Jul 14, 2020
The safety the release describes is that of the two double-blind Phase 3 trials (CAMP-1 and CAMP-2)
8-K · Jul 14, 2020: There were no serious adverse events reported in VP-102-treated subjects
8-K · Jul 14, 2020. The safety concern in the letter is about using the device: we remain concerned that your proposed cantharidin combination product is not safe for use by HCPs
FDA · Jul 13, 2020 · p. 15, because the risk of accidental exposure will outweigh the benefit of the treatment with this combination product
FDA · Jul 13, 2020 · p. 15. The July 14, 2020 press release does not mention accidental exposure, the ampule or use errors. 8-K · searched
The August 2020 quarterly report described the letter the same way: The Agency noted no clinical safety or efficacy deficiencies were identified.
8-K · Aug 5, 2020
The July release also refers to an earlier FDA letter: The Company had previously disclosed receipt of a letter from the FDA in which the agency noted deficiencies that precluded discussion of labeling and post-marketing requirements/commitments.
8-K · Jul 14, 2020
Nine days after the letter was announced, Verrica named a new Head of Drug Development who will oversee all non-clinical aspects of drug development for Verrica’s product candidates, including CMC (“Chemistry, Manufacturing, and Controls”) and Regulatory Affairs
8-K · Jul 23, 2020.
How the company's account of the next two letters compares: How did Verrica's account of its three FDA letters change?
Follow the thread
- What did the FDA's first letter on VP-102 object to?“Not safe for use by HCPs”
- How did Verrica's account of its three FDA letters change from 2020 to 2022?“No Clinical Safety or Efficacy Issues Identified”
This investigation connects to
- What did “no efficacy or safety issues” cover in these FDA letter announcements?Cross-investigation · Shared concern · with CorMedix, Replimune
The documents, by date
The passages quoted
FDA Complete Response Letter, July 13, 2020 · page 15
In summary, we remain concerned that your proposed cantharidin combination product is not safe for use by HCPs. We are concerned that the risk of accidental exposure will outweigh the benefit of the treatment with this combination product. Inherent design issues exist with this product that may contribute to serious harm if accidental exposure occurs during use. Thus, additional mitigation strategies are needed and could include the need for device design changes to optimize applicator use along with other revisions to the product user interface taking into consideration our previously identified concerns and the data collected from your HF validation study. After you implement additional risk mitigation strategies/modifications, we recommend you conduct an additional HF validation study to ensure that these modifications address the observed use errors and use difficulties and do not introduce any new risks.Open at the source →
Verrica Pharmaceuticals Form 8-K, filed July 14, 2020
The July 14, 2020 press release does not mention accidental exposure, the ampule or use errors.
Open the document →Verrica Pharmaceuticals Form 8-K, filed July 14, 2020
Verrica believes that the positive results from its two double-blind Phase 3 trials (CAMP-1 and CAMP-2), which evaluated VP-102 compared to placebo in patients two years of age and older diagnosed with molluscum, have demonstrated favorable safety, efficacy and tolerability. Specific results from the CAMP-1 and CAMP-2 studies showed that 46 and 54 percent, respectively, of subjects treated with VP-102 achieved complete clearance of all baseline and new molluscum lesions at the end of the trials (Day 84), versus 18 and 13 percent, respectively, of subjects in the vehicle groups (p<0.0001). There were no serious adverse events reported in VP-102-treated subjects, and most adverse events reported in subjects receiving VP-102 were local skin reactions and mild to moderate in severity.Open at the source →
Verrica Pharmaceuticals Form 8-K, filed July 14, 2020
Complete Response Letter Requests Additional Chemistry, Manufacturing, and Controls (CMC) and Human Factors Information – – No Clinical Safety or Efficacy Issues IdentifiedOpen at the source →
Verrica Pharmaceuticals Form 8-K, filed July 14, 2020
The Company had previously disclosed receipt of a letter from the FDA in which the agency noted deficiencies that precluded discussion of labeling and post-marketing requirements/commitments.Open at the source →
Verrica Pharmaceuticals Form 8-K, filed July 14, 2020
According to the CRL, the FDA is seeking additional information regarding certain aspects of the CMC (Chemistry, Manufacturing, and Controls) process for the drug/device combination, as well as Human Factors validation. Importantly, the FDA did not identify any clinical deficiencies.Open at the source →
Verrica Pharmaceuticals Form 8-K, filed July 23, 2020
As Head of Drug Development, Dr. Brad Catalone will oversee all non-clinical aspects of drug development for Verrica’s product candidates, including CMC (“Chemistry, Manufacturing, and Controls”) and Regulatory Affairs.Open at the source →
Verrica Pharmaceuticals Form 8-K, filed August 5, 2020
in which the FDA requested additional information regarding certain aspects of the CMC (Chemistry, Manufacturing, and Controls) process, as well as Human Factors validation. The Agency noted no clinical safety or efficacy deficiencies were identified.Open at the source →