ajt/shutterstock.com
Opana ER Pulled from U.S. Market
Last month, the U.S. Food and Drug Administration (FDA) asked Endo Pharmaceuticals to remove oxymorphone hydrochloride extended release (Opana ER) from the U.S. market due to public health consequences related to abuse. The agency has concerns that the risks presented by the treatment do not outweigh its benefits.1 On July 6, after careful consideration, Endo Pharmaceuticals announced that it will follow the June 2017 FDA ruling and will voluntarily withdraw Opana ER from the U.S. market.2
The company will work with the FDA to coordinate the organized removal of Opana ER from the market to minimize treatment disruption for patients, enabling patients to receive sufficient guidance from their healthcare providers about alternate pain management. Patients taking Opana ER should discuss treatment options with their physician, and prescribers should contact patients to discuss alternative treatment options.
Endo International continues to believe in the favorable benefit–risk profile of Opana ER for managing severe pain in appropriate patients—those who require a daily, around-the-clock, long-term opioid treatment and for whom alternative treatment options are inadequate. Endo International also remains confident in the clinical research and data demonstrating the treatment’s safety and efficacy.
Upadacitinib Meets Study Endpoints to Treat RA
Upadacitinib (ABT-494) is an oral, once-daily JAK1 inhibitor in Phase 3 clinical trials for treating rheumatoid arthritis (RA).3 The SELECT Phase 3 trial by the manufacturer AbbVie is evaluating the treatment in more than 4,000 patients with moderate to severe RA in six different studies.
A recent clinical trial, SELECT-NEXT, evaluated upadacitinib in patients with moderate to severe RA who do not adequately respond to treatment with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).4 After Week 12, the study met its primary and secondary endpoints. The primary endpoints included ACR20 and low disease activity. Key secondary endpoints included ACR50, ACR70 and clinical remission. These results were achieved by patients taking 15 or 30 mg upadacitinib once daily.
For patients receiving 15 or 30 mg upadacitinib, the Week 12 results showed a 64% and 66% ACR20 response rate, respectively, compared with a 36% achievement in ACR20 for placebo-treated patients. The ACR50 response rates for upadacitinib-treated patients were 38% and 43%, respectively, vs. 15% for placebo-treated patients. And the ACR70 responses for upadacitinib-treated patients were achieved in 21% of patients treated with 15 mg and 27% of patients treated with 30 mg vs. 6% of placebo-treated patients. Overall, low disease activity was achieved in 48% of upadacitinib-treated patients receiving either dose compared with 17% of placebo-treated patients. Clinical remission was achieved by 31% of 15 mg upadacitinib-treated patients and 28% of 30 mg upadacitinib-treated patients. Only 10% of placebo-treated patients achieved clinical remission. All study endpoints were considered statistically significant (P<0.001) compared with placebo.
The safety of upadacitinib is still being evaluated. The treatment is also in Phase 3 trials for psoriatic arthritis and is being investigated to treat Crohn’s disease, ulcerative colitis and atopic dermatitis.
Abatacept Prefilled Syringes Now Available
On June 8, the FDA announced the availability of a new subcutaneous abatacept (Orencia) dosing option for patients at least two years old with moderate to severe active polyarticular juvenile idiopathic arthritis (JIA).5 Now available in a prefilled syringe, this new dosage form offers patients, caregivers, physicians and other healthcare providers the ability to administer abatacept at home.
The safety experience and immunogenicity for subcutaneously administered abatacept in Study JIA-2 were consistent with the intravenous Study JIA-1, with no reported cases of hypersensitivity reactions. The incidence of local injection-site reactions was 4.4%.
Generic 2% Diclofenac Sodium Now Available
A 2% diclofenac sodium topical solution is now available in a generic form to treat knee osteoarthritis.6 The treatment was originally approved by the U.S. Food and Drug Administration (FDA) in 2014 under the brand name Pennsaid from Horizon Pharmaceuticals.7
Post-Teriparatide Denosumab for Osteoporosis
After 18–24 months, the sequential treatment of osteoporosis with denosumab promoted significantly greater bone mineral density (BMD) increases compared with bisphosphonates in women with severe postmenopausal osteoporosis who had stopped teriparatide treatment. This result comes from a retrospective, observational study presented at the 19th European Congress of Endocrinology in Lisbon, Portugal.8
During the study, 140 women from a clinic in Slovenia used bisphosphonates (i.e., alendronate, risedronate, ibandronate or zoledronic acid) with denosumab (n=70) or without denosumab (n=70) after receiving teriparatide treatment. All patients received 1,000 IU vitamin D3 daily, with instructions to take 1,200 mg calcium daily. Lumbar spine BMD, total hip BMD and femoral neck BMD were measured via DXA when teriparatide was stopped and after 12 months of denosumab treatment. Lower BMD increases were noted for bisphosphonate-only-treated patients compared with denosumab-treated patients in femoral neck and lumbar spine BMDs. A trend toward a lower rate of new fractures with denosumab compared with bisphosphonates (5.7% vs. 17.1%, respectively) was also noted.9 Initially, around 90% of patients had prevalent vertebral fractures. The patients also had similar baseline clinical characteristics, except that total hip BMD was greater for denosumab-treated patients compared with bisphosphonate-treated patients (0.739 g/cm3 vs. 0.694 g/cm3, respectively).
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- U.S. Food and Drug Administration. FDA News Release: FDA requests removal of Opana ER for risks related to abuse. 2017 Jun 8..
- Endo International Plc. News release: Endo provides update on Opana ER. PR Newswire. 2017 Jul 6.
- AbbVie Inc. News release: AbbVie’s upadacitinib (ABT-494) meets all primary and ranked secondary endpoints in phase 3 study in rheumatoid arthritis. PR Newswire. 2017 Jun 7.
- U.S. National Institutes of Health. A study comparing ABT-494 to placebo in subjects with rheumatoid arthritis on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) who have an inadequate response to csDMARDs alone (SELECT-NEXT). ClincalTrials.gov. 2017 Jun 29.
- Bristol-Myers Squibb Co. News release: Bristol-Myers Squibb announces availability of new Orencia (abatacept) subcutaneous administration option for patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA). 2017 Jun 8.
- U.S. Food and Drug Administration. Drugs@FDA: FDA approved drug products—diclofenac sodium 2% topical solution. 2017 May 15.
- U.S. Food and Drug Administration. Drugs@FDA: FDA approved drug products—Pennsaid (diclofenac sodium 2% topical solution). 2014 Jan 16.
- Kocjan T, Rajic AS, Sever MJ et al. The effect of denosumab or bisphosphonates in women with severe postmenopausal osteoporosis after completion of teriparatide treatment. Endocrine Abstracts. 2017:49[abstract OC10.4].
- Berrie C. Denosumab more effective than bisphosphonates in treating severe, post-menopausal osteoporosis post-teriparatide: Presented At ECE. First Word: Pharma. 2017 May 26.
