Avinza: Elan

Current Opinion in Investigational Drugs

Volumn 3, Issue 9, 2002, Pages 1369-1372

  Semenchuk, Marilyn R ^a  

^a NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MORPHINE SULFATE; NARCOTIC ANALGESIC AGENT; NONSTEROID ANTIINFLAMMATORY AGENT; OPIATE AGONIST; OXYCODONE; PARACETAMOL;

ANALGESIC ACTIVITY; CLINICAL TRIAL; CONSTIPATION; CONTROLLED RELEASE FORMULATION; DROWSINESS; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG HALF LIFE; DRUG METABOLISM; DRUG SAFETY; DRUG SYNTHESIS; HUMAN; MAXIMUM TOLERATED DOSE; NAUSEA; NEPHROTOXICITY; PAIN; PATIENT COMPLIANCE; PRURITUS; REVIEW; SINGLE DRUG DOSE; STRUCTURE ACTIVITY RELATION; VOMITING; XEROSTOMIA;

ANIMALS; CLINICAL TRIALS; DELAYED-ACTION PREPARATIONS; DRUG INDUSTRY; HUMANS; MORPHINE; PAIN;

EID: 0036771122     PISSN: 14724472     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (26)

1. 220806 Annual Report 1996 - Elan Corp Plc. Elan Corp plc Annual Report 1996
2. 223862 Elan Technologies. From mind to market. Elan Corp Plc Company Brochure 1995
3. 258761 Targon Corporation, a subsidiary of CYTOGEN Corporation, licenses Morphelan once-daily morphine product from Elan Pharmaceutical Technologies. Cytogen Corp Press Release 1999 August 11
4. 294833 CYTOGEN announces divestiture of Targon venture/receives $4 million in cash. Cytogen Corp Press Release 1998 August 14
5. 299770 Ligand and Elan announce strategic alliance. Ligand Pharmaceuticals Inc/Elan Corp Plc Press Release 1998 September 29
6. 304306 Ligand and Elan launch strategic alliance/provides ligand with up to $130 million in funding, rights to Morphelan for HIV and oncology markets. Ligand Pharmaceuticals Inc Press Release 1998 November 09
7. 304573 Elan aiming at oncology in $130M deal with ligand. Bioworld International 1998 3 40 3
8. 349752 Ligand pays Elan milestone for Morphelan development progress. Ligand Pharmaceuticals Inc Press Release 1999 December 08
9. 353587 Chase H&Q 18th Annual Healthcare Conference (Part II), San Francisco, CA, USA. Hookes J IDDB Meeting Report 2000 January 10-13
10. 354434 A guide to product submissions and approvals in 2000. Lehman Brothers Inc 2000 January 13
11. 370342 Ligand pays Elan milestone for Morphelan - NDA submission. Ligand Pharmaceuticals Inc Press Release 2000 June 08
12. 410253 'Sprinkle dosing' of a new, once a day oral extended-release morphine formulation, Morphelan ROER. Eliot L, Loewen G, Butler J, Tembe E, Devane J Proc Am Soc Clin Oncol 2001 20 Pt 2 Abs 2073 Pharmacokinetics of Avinza sprinkle-dose versus intact capsule.
13. 443220 Ligand reports record financial results for full year and fourth quarter 2001. Ligand Pharmaceuticals Inc Press Release 2002 March 11
14. 444414 FDA approves AVINZA once-daily for chronic, moderate-to-severe pain. Ligand Pharmaceuticals Inc Press Release 2002 March 21 Open-label study of Avinza in osteoarthritic patients.
15. 444744 Elan receives FDA approval of Avinza a once-daily capsule for chronic, moderate-to-severe pain. Elan Corp Plc Press Release 2002 March 21
16. 444773 Ligand Avinza once-daily dosing will be core promo message for Elan opioid. FDC Reports Pink Sheet 2002 64 12 23-24 Planned phase IV Avinza studies.
17. 450186 AVINZA phase III study published in leading pain journal shows that new drug reduces pain, improves sleep in osteoarthritis patients compared to placebo. Ligand Pharmaceuticals Inc Press Release 2002 May 01 Phase III trial of Avinza once-daily versus MS Contin twice-daily versus placebo.
18. 450188 AVINZA pharmacokinetic study published in leading pain journal demonstrates that new drug has more stable and consistent PK profile than MS Contin. Ligand Pharmaceuticals Inc Press Release 2002 May 01 Pharmaceuticals of Avinza versus MS Contin.
19. 450266 Elan reports first quarter 2002 financial results. Elan Corp Plc Press Release 2002 May 02
20. 450281 Ligand reports financial results for first quarter 2002: Total revenues up 46%, per share loss down 50% product sales increase by 59%, operating loss decreases by 73% company provides financial outlokk and AVINZA launch update; Ligand to redeem Glycomed convertible subordinated debentures to complete elimination of 98% of year-end 2001 long-term debt. Ligand Pharmaceuticals Inc Press Release 2002 May 02
21. 451151 Pharmacokinetic evaluation of a sprinkle-dose regimen of a once-daily, extended-release morphine formulation. Eliot L, Butler J, Devane J, Loewen G Clin Ther 2002 24 2 260-268 Report of a pharmacokinetic study of Avinza in humans administered either sprinkled on food or swallowed intact; both routes were bioequivalent.
22. 451155 Steady-state pharmacokinetic comparison of a new, extended-release, once-daily morphine formulation, Avinza, and a twice-daily controlled-release morphine formulation in patients with chronic moderate-to-severe pain. Portenoy RK, Sciberras A, Eliot L, Loewen G, Butler J, Devane J J Pain Symptom Manage 2002 23 4 292-300 Pharmacokinetic study of Avinza in humans.
23. 451157 Efficacy and safety of a once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: Results from a randomized, placebo-controlled, double-blind trial and an open-label extension trial. Caldwell JR, Rapoport RJ, Davis JC, Offenberg HL, Marker HW, Roth SH, Yuan W, Eliot L, Babul N, Mikkelsen Lynch PM J Pain Symptom Manage 2002 23 4 278-291
24. 452072 Avinza (morphine sulfate extended-release capsules) New Drug Application. Elan Corp Plc March 20 2002 www.fda.gov/cder/foi/label/2002/21260lbl.pdf Details the components of Avinza capsules.
25. 457470 Ligand updates AVINZA launch progress, revises second quarter revenue guidance, and reiterates full-year revenue guidance with different product sales mix. Ligand Pharmaceuticals Inc Press Release 2002 July 09.
26. 458232 Ligand pharmaceuticals: Initiating coverage with buy rating; Avinza in the spotlight. Chovav M, Kim K UBS Warburg (US) 2002 June 17