Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS

Inclusion Criteria:

• Be able and willing to give a signed informed consent and to follow studyinstructions

• Be male or female, ≥ 18 years of age

• Have a history of IC/BPS for at least 9 months prior to the study

• Have received a cystoscopy in association with their diagnosis of IC/BPS within 1year of screening.

• Have a score of ≥ 16 and ≤ 30 on the Pelvic Pain and Urgency/Frequency (PUF)questionnaire, completed at screening

• Have an episode of acute bladder pain of moderate to severe intensity with a minimumscore of 5 on the 11-point bladder pain NRS at time of screening and 15 minutes postvoid immediately prior to study drug administration.

• Have previously received a therapeutic intravesicular anesthetic treatment accordingto medication history

Exclusion Criteria:

• For females, have a positive pregnancy test at screening or be pregnant or lactating

• Males who are sexually active with females and are not willing to commit to anacceptable method of birth control for the duration of the

• Postmenopausal women who, if taking hormone replacement therapy, have not beenstabilized on a regimen of hormone replacement therapy within 3 months of screening

• Have a known hypersensitivity to heparin or lidocaine

• Have used any local anesthetic by any route within 48-hours prior to study drugadministration, or used a lidocaine patch or lidocaine containing topical compoundswithin 14 days prior to study drug administration

• Have used a tricyclic antidepressant, or a gamma-aminobutyric acid (GABA) analogue (gabapentin or pregabalin), unless taking a stable dose of the medication for ≥ 3weeks. The stable dose of gabapentin may not exceed 1,200 mg per day, and the stabledose of pregabalin may not exceed 150 mg per day

• Have used any pain medication within 6 hours prior to study drug administration

• Have used narcotics or medical marijuana ≤ 3 weeks prior to study entry

• Have used prohibited drugs as determined by self-report, positive urine drug screen,or in the opinion of the investigator be under the influence of drugs affectingmentation precluding their ability to follow the study protocol or bias studyresults

• Have a known abnormal laboratory test value that, in the investigator's judgement,is clinically significant.

• Have a neurogenic bladder or other disorder that, in the opinion of theinvestigator, may cause neurogenic bladder (including Parkinson's disease, multiplesclerosis, epilepsy, myasthenia gravis, movement disorders, spinal cord damage)

• Have pain or a pain disorder that, in the opinion of the investigator, would make itdifficult to discriminate pelvic pain of bladder origin from the other pain

• Have any of the following central nervous system (CNS) conditions that in theopinion of the investigator would impact the subject's study participation due totheir ability to follow the study protocol or bias study results, severe diagnosed:major depressive disorder, bipolar disorder, schizophrenia, general anxietydisorder, attention deficit disorder, obsessive compulsive disorder, or other majorcentral nervous system disorder

• Have history of arrhythmias, conduction disturbances, or cardiac disease, or anycoexisting medical condition that, in the opinion of the investigator, may besignificant or interfere with study procedures or interpretation of study results

• Had anesthetic bladder instillation therapy within 14 days prior to study entry

• Had an in-office cystoscopy within 7 days of study drug administration

• Had dilatation (hydrodistension) of bladder within 3 months of study entry

• Evidence or suspected presence of cancer detected during cystoscopy 7 days prior toor at time of initial screening

• Has received any investigational drug or device within 30 days prior to screening

• Is currently enrolled in another investigational drug or device study

• Is unwilling or unable to abide by the requirements of the study

• Have an actively bleeding lesion or area in the bladder as detected by dipstickurinalysis and investigator assessment, immediately prior to randomization

• Have a history of coagulopathy or taking anticoagulants.

• Are taking any of the following medications, which are inducers of CYP1A2 and/orCYP3A4: Phenytoin, Carbamazepine, St. John's Wort, Phenobarbital, Rifampin

• Have had any of the following:

• Bacterial cystitis within 30 days as demonstrated by a positive urine culture (≥ 105 bacteria per mL)

• History of pelvic irradiation or radiation cystitis

• History or presence of uterine, cervical, pelvic, rectal, ovarian, or vaginalcancer

• History of benign or malignant bladder tumors

• Current chemotherapy

• History or presence of tuberculous cystitis

• History or presence of chemical cystitis, including that due tocyclophosphamide

• History or presence of urinary schistosomiasis

• Bladder or ureteral calculi

• Clinically significant infectious vaginitis

• Currently uncontrolled genital herpes

• History or presence of urethral diverticulum

• Presence of bladder fistulae

• History of ketamine use