A Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia

Inclusion Criteria: * Subject has a body mass index (BMI) ≤ 45 kg/m\^2. * Female subject must either: * Be of nonchildbearing potential: * Postmenopausal (defined as at least 1 year without any menses) prior to Screening, or, * Documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy). * Or, if of childbearing potential, agree not to try to become pregnant during the study and for 28 days after the final study drug administration, have a negative blood pregnancy test at Screening and negative urine test on Day 1, and if heterosexually active, agree to consistently use 1 form of highly effective birth control starting at Screening and throughout the study period and for 28 days after the final study drug administration. * Female subject must agree not to breastfeed at Screening and throughout the study period, and for 28 days after the final study drug administration. * Female subject must not donate ova starting at Screening, throughout the study period, and for 28 days after the final study drug administration. * Male subject must not donate sperm starting at Screening and throughout the study period, and for 90 days after the final study drug administration. * A sexually active male subject with female partner(s) who are of childbearing potential is eligible if: * Agree to use a male condom starting at screening and continue throughout study treatment and for 90 days after the final study drug administration. If the male subject has not had a vasectomy or is not sterile the male subjects female partner(s) is utilizing 1 form of highly effective birth control starting at screening and continue throughout study treatment, and for 90 days after the male subject receives final study drug administration. * Male subject with a partner of child-bearing potential, or a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom throughout the study period and for 90 days after the final study drug administration. * Subject meets the American College of Rheumatology (ACR) 1990 fibromyalgia diagnostic criteria at Screening: * Widespread pain for at least 3 months, defined as the presence of all of the following: Pain above and below the waist and pain in the axial skeleton (cervical spine or anterior chest or thoracic spine or low back) must be present. * Pain in at least 11 of 18 tender point sites on digital palpation. Digital palpation should be performed with an approximate force of 4 kg. * Subject meets the ACR 2010 fibromyalgia diagnostic criteria at Screening: * Widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5 or WPI 3-6 and SS scale score ≥ 9. * Symptoms have been present at a similar level for at least 3 months. * The subject does not have a disorder that would otherwise explain the pain. * Subject has a pain score ≥ 4 on the revised fibromyalgia impact questionnaire (FIQR) pain item at Screening. * Subject is compliant with daily pain recordings during the Baseline Diary Run-In period, as defined by the completion of a minimum of 5 of 7 daily average pain ratings and agrees to complete daily diaries throughout the duration of the study. * Subject has a mean daily average pain score ≥ 4 and ≤ 9 on an 11-point 0 to 10 NRS as recorded in the subject e-diary during the Baseline Diary Run-In period, and meeting pre-specified criteria for daily average pain scores. * Subject agrees to use only acetaminophen as rescue medication for fibromyalgia pain throughout the course of the trial (up to 1000 mg per dose and not to exceed 3000 mg/day). * Subject agrees not to initiate or change any non-pharmacologic interventions (including normal daily exercise routines, chiropractic care, physical therapy, psychotherapy, and massage therapy) during the course of the study. Non-pharmacologic interventions must be stable for a minimum of 30 days prior to Screening. And subject agrees to maintain usual level of activity for the duration of the study. * Subject is capable of completing study assessments and procedures. * Subject agrees not to participate in another interventional study from Screening through the End of Study (EOS) visit. Exclusion Criteria: * Subject has received an investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to Screening. * Subject has had no meaningful improvement from 2 or more prior treatments (commercially available) for fibromyalgia (in at least 2 pharmacologic classes). * Subject has had known hypersensitivity or intolerance to the use of acetaminophen or associated formulation components; known hypersensitivity to the formulation components of ASP8062. * Subject has pain due to diabetic peripheral neuropathy, post-herpetic neuralgia, traumatic injury, prior surgery, complex regional pain syndrome, or other source of pain that would confound or interfere with the assessment of the subject's fibromyalgia pain or require excluded therapies during the subject's study participation. * Subject has infectious or inflammatory arthritis (for example, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, gout), autoimmune disease (for example, systemic lupus erythematosus), or other widespread rheumatic disease other than fibromyalgia. * Subject has a current, untreated moderate or severe major depressive disorder as assessed by the Mini-International Neuropsychiatric Interview (M.I.N.I.). Subject with current, treated major depressive disorder can be included provided that it is without clinically significant changes in symptoms while on the same dose of a protocol allowed antidepressant for greater than 60 days prior to Screening. * Subject has initiated any non-pharmacologic interventions for the treatment of fibromyalgia or depression within 30 days prior to Screening or during the Screening period. * Subject has a history of any psychotic and/or bipolar disorder as assessed by the M.I.N.I. * Subject has a Hospital Anxiet…

Reproduced word-for-word from the public registry record — the study team can answer questions about it.