dm+d

Unassigned

New Medicines

YcanthMolluscum contagiosum

Information

Ycanth
New molecular entity
Verrica Pharmaceuticals
Verrica Pharmaceuticals

Development and Regulatory status

None
None
Not approved
May 22FDA issues a second complete response letter for VP-102 after the company ´s contract manufacturing organisation, Sterling Pharmaceuticals Services was placed on Official Action Indicated (OAI) status by the FDA, the most serious category of violation. An OAI suggests that objectionable conditions were found, and regulatory action is recommended. Verrica stated that the deficiency was due to issues were flagged at a general inspection of Sterling [9].
Dec 21Verrica Pharmaceuticals announces acceptance by FDA of resubmission of New Drug Application for VP-102 as treatment of molluscum contagiosum; with a PDUFA goal date is 24/5/22 [8].
Sep 21Company received a complete response letter from US FDA which identified deficiencies at the facility of a contract manufacturing organisation Verrica is working with, raising general quality issues at the facility. Verrica have said that the contract manufacturing has undertaken corrective measures to address the FDA’s concerns and that it is expecting a “satisfactory resolution” of the identified deficiencies within 30 days. Verrica plan to meet with the FDA to ensure a path forward. In the CRL, the FDA did not identify any deficiencies related to the manufacturing of cantharidin and there were also no clinical, safety or chemistry, manufacturing or controls concerns identified. [8]
Nov 20Following a meeting with the FDA, Verrica announced they plan to resubmit the NDA in Q1 2021 [7].
Jul 20The FDA has issued a complete response letter (CRL) regarding the previously submitted NDA. The FDA did not identify any clinical deficiencies; however, they are 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 [6].
Sep 19Verrica Pharmaceuticals has submitted an NDA to the US FDA for MC [4].
Feb 19Verrica Pharmaceuticals announced intention to submit NDA to US FDA for Molluscum contagiosum (MC) in 2H 2019.[3]

Category

Protein phosphatase 1 and 2a inhibitor cantharidin 0.7% presented as a film-forming solution for topical use
Molluscum contagiosum is a common and contagious but generally harmless condition and usually self-limiting condition caused by a pox virus. It causes spots on skin and is most common in children and young adults [1].
Molluscum contagiosum
Topical

Trial or other data

Sep 20In two identical PIII trials (CAMP-1 and CAMP-2; n=582), topical application of cantharidin, an extract from blister beetles, every 21 days for a maximum of 4 treatments resulted in higher rates of complete lesion clearance compared to vehicle (46.3% vs. 18% and 54.0% vs. 13%, respectively) [5].
Mar 19Further data from CAMP-1 and CAMP-2 trials in 528 pts with MC. Pts were treated once every 3 weeks for up to a total of 12 weeks with VP-102 (a topical treatment containing a solution of 0.7% cantharidin in a single-use applicator). By the end of the study, 46% of treated pts in CAMP-1 and 54% of treated pts in CAMP-2 had complete clearance of all treatable molluscum lesionsvs. placebo; 18% and 13%, respectively. VP-102 performed similarly in the mean reduction of the number of lesions: 69% and 83% reduction in CAMP-1 and CAMP-2. Placebo patients in CAMP-1 had a 20% increase in lesions, while those in CAMP-2 had a 19% reduction.[2,3]
Jan 19PII Innovate open-label trial (VP-102-103; NCT03186378) that evaluated the safety, efficacy and systemic exposure of VP 102 completed in 33 children. with MC in the US.
Jan 19Topline data from the phase III CAMP-1 and CAMP-2 trials showed complete clearance of of all treatable molluscum lesions at day 84 when treated with VP 102 vs. 18% and 13% of pts in the placebo groups (p < 0.0001). Pts treated with VP 102 had a 69% and 83% mean reduction in the number of molluscum lesions, in CAMP-1 and CAMP-2 trials, respectively vs. 20% and 19% for pts on placebo. In these trials, VP 102 was generally safe and well-tolerated, with mild to moderate side-effects which were; application site vesicles, pain , pruritus, erythema, scab, discolouration and dryness. No treatment-related serious adverse events were observed.[2]
Sep 18Positive safety and efficacy results announced from PII Innovate open-label trial (VP-102-103; NCT03186378). A median reduction in molluscum lesions of 98% vs. baseline across all patients were observed, and 50% of pts who completed the trial showed complete clearance of their treatable molluscum lesions, at the end of week 12.[2]
Mar 18A double-blind, parallel, prospective, randomised PIII trial is initiated to evaluate the safety and efficacy of VP 102 in pts with molluscum contagiosum (CAMP-1, NCT03377790). The trial recruited 266 pts in the US.[2]
Feb 18PIII CAMP-2 double-blind, parallel, prospective, randomised trial (NCT03377803; VP102-102) initiated to evaluate the safety and efficacy of VP 102 in pts with MC. The trial recruited 262 pts in the US.[2]