Form: 8-K

Current report filing

August 10, 2020

Documents

 

Exhibit 99.2

 

INNOVATING FOR PATIENTS Nasdaq TRVN August 2020

 

 

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5432-1-ba_corporate_page_14.jpg Customer Engagement Strategy 14

 

 

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5432-1-ba_corporate_page_30.jpg TRV045: Ne'$-Gene"a$ion 51P Mod%la$o" fo" CN5 Di#o"de"# N,> MOA (; "1P, >0;/6<; (::6*0(;,+ 3@47/67,50( *:*67*7 P&.3 *75437* 100 ** * 80 M ,1) C646AE@CD :? E96 C', A=2J F?:BF6 C@=6 :? >@5F=2E:?8 ?6FC@EC2?D>:DD:@? / >6>3C2?6 6I4:E23:=:EJ 60 40 d yperalgesia 20 M #? 2?:>2=D, -+/045 C6G6CD65 A24=:E2I6=-:?5F465 9JA6C2=86D:2 H:E9@FE :>>F?6-DFAAC6DD:?8 24E:G:EJ 0 F)-'.+), .% 0.03 m g/kg po TR 045 1.0 m g/kg sc - - :?8@=:>@5 C65F465 =J>A9@4JE6D 3J 78% -+/045 925 ?@ 67764E @? =J>A9@4JE6D A:4.)7 L=25-45*3.& 6 5 4 3 2 1 0 ** Vehicle M '@?-@A:@:5 &(A H:E9 3C@25 A@E6?E:2= 7@C C', :?5:42E:@?D - - C9C@?:4 A2:?, C#)', 5:236E:4 ?6FC@A2E9J EA:=6ADJ, 24FE6 / 49C@?:4 A2:? 6G2=F2E:@?D F?56CH2J F)-'.+), .% 0.03 m g/kg po TR 045 3.7 m g/kg sc C$+) @BHF8 @B78? +46?<G4K8? @:I>:, <.C. BA D4LF , 3, 5, 7. #LC8E4?:8F<4 @84FHE87 4F % ABA-E8FCBAF8 GB 0.4 : 1BA !E8L 9<?4@8AG IF. 54F8?<A8, G8FG87 30S 49G8E 7BF<A: BA D4L 3. 'L@C;B6LG8F @84FHE87 49G8E 3 74LF B9 7BF<A:. D4G4 4E8 @84A O F.8.@. A 5-7 @<68I:EBHC. C<0.05 BE C<0.0 IF. 6BAGEB? 30 P *$)# *a% L/&)#(c/, + (103 c %%+ I μL) % W$,# N('-R +)('+ ,( Pa$' S,$&-%-+ alone N. 0&%3$2).-%&1/)2& 3.75 %.1)-' (B?. -.;B1) taxel-induce Pacli h

 

 

5432-1-ba_corporate_page_31.jpg 5)9)2%: I2239%7-9) CNS C314%2< OLINVYK !) !$d!ca*ed !$ ad+"*) f%( * e #a$age#e$* %f ac+*e &a!$ )e,e(e e$%+g *% (e'+!(e a$ !$*(a,e$%+) %&!%!d a$a"ge)!c a$d f%( - %# a"*e($a*!,e *(ea*#e$*) a(e !$ade'+a*e. P"ea)e )ee I#&%(*a$* Safe*. I$f%(#a*!%$ !$c"+d!$g BOXED WARNING a* * e e$d %f &(e)e$*a*!%$. F+"" P(e)c(!b!$g I$f%(#a*!%$ a* ---.OLINVYK.c%#. 31 )C )8J C;8@<64? AG<GLy (*A (86;4A<F@ B9 A6G<BAy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

 

 

5432-1-ba_corporate_page_32.jpg APPENDIX 32

 

 

5432-1-ba_corporate_page_33.jpg R3&867 C0-2-'%0 D)9)0341)27 P53+5%1 OLINVYK *+, #! #& > 1,900 #& #-# ,a$* Phase 1 Phase 2 Phase 3 M N4 )47&,* &)/9782*387 7@C 6=56C=J / C6?2==J :>A2:C65 '@ <?@H? 24E:G6 >6E23@=:E6D 4 -*&)-84--*&) 86.&17 :7. I$ 2465-.3*: M M M M #/ @A:@:5 677:424J +2A:5 @?D6E @7 24E:@? 06==-492C24E6C:K65 C6DA:C2E@CJ D276EJ / !# E@=6C23:=:EJ %@H C2E6D @7 G@>:E:?8 2?5 C6D4F6 2?E:6>6E:4 FD6 M L&6,* 7&+*8= 789)=: M +62=-H@C=5 FD6 :? 4@>A=6I A2E:6?ED 2?5 E2C86E DFC86C:6D P"ea)e )ee I#&%(*a$* Safe*. I$f%(#a*!%$ !$c"+d!$g BOXED WARNING a* * e e$d %f &(e)e$*a*!%$. F+"" P(e)c(!b!$g I$f%(#a*!%$ a* ---.OLINVYK.c%#. 33 FH5=86GF 8KCBF87 GB *'$)12& <A +; 3 y C4G<8AGF GE84G87 J<G; *'$)12& <A +;2 4A7 +;3 ,535

 

 

5432-1-ba_corporate_page_34.jpg P5-1%5< E**-'%'< E2(43-27 A',-)9)( -2 :3 P-937%0 S78(-)6 OLIN%'K (*/0,=,+ I% 67060+ ,--0*(*@ # < 0.0001 p == 0.0004 80% p < 0.0001 70% 80% 70% p == 0.029 60% 60% 50% 50% 40% 40% 30% 30% 20% 10% 20% 10% 0% 0% #8-/1.; 0. 1 93 0. 35 93 0. 5 93 #8-/1.; 0. 1 93 0. 35 93 0. 5 93 -*)#%/)$),% -*)#%/)$),% P"ea)e )ee I#&%(*a$* Safe*. I$f%(#a*!%$ !$c"+d!$g BOXED WARNING a* * e e$d %f &(e)e$*a*!%$. F+"" P(e)c(!b!$g I$f%(#a*!%$ a* ---.OLINVYK.c%#. 34 *'$)12& E8:<@8AF .5 @: ?B47<A: 5B?HF, J<G; 0. , 0.35, BE 0.5 @: 4I4<?45?8 BA 78@4A7 8I8EL @<AHG8F. D<FC?4L87 C-I4?H8F 4E8 9BE *'$)12& IF. C?4685B J<G; #B6;58E: @H?G<C?<6<GL 47=HFG@8AG. 1<F6HF< - 8G 4?. % +4<A -8F. 20 y 2 27P 43. +H5?<F;87 20(4E. .<A:?4 )& 8G 4?. +4<A +E46G. 20 y7 5-73 . +H5?<F;87 20%HA 04. A-"+'&1)$ 0&1/.-%&0 0"2& A-"+'&1)$ 0&1/.-%&0 0"2& H):, <1;;=-$7.< <1;;=-

 

 

5432-1-ba_corporate_page_35.jpg OLIN"$K: I" O4-3-( E**-'%'< -2 2 P,%6) 3 RC 6 $<=,A 1 (!:<078-,1+ D H):, %1;;=-) 3 $CA 9.025.6: :;<-2.-(0.1, 0.35, 0.5 50) =:. 84*,.+7 *44 -7:.: $<0.01 =:. 84*,.+7 10 9 8 7 6 5 4 3 2 1 0 P/%')&2 (1=? ) 0LIN#$K 0 10+ (1=?6) 0LIN#$K 0 350+ (1=? ) 0LIN#$K 0 50+ (1=? ) 0 4 8 12 16 20 24 28 32 36 40 44 48 10 9 8 7 6 5 4 3 2 1 0 $<=,A 2 ("4);<1+ $=:/-:A D $7.< %1;;=-) 3 $CA 9.025.6: :;<-2.-(0.1, 0.35, 0.5 50) =:. 84*,.+7 0.35 I 0.5 50 -7:.: $<0.02 =:. 84*,.+7 P/%')&2 (1=81) 0LIN#$K 0 10+ (1=??) 0LIN#$K 0 350+ (1=80) 0LIN#$K 0 50+ (1=80) 0 4 8 12 16 20 24 T)-& ((/412) 35 P"ea)e )ee I#&%(*a$* Safe*. I$f%(#a*!%$ !$c"+d!$g BOXED WARNING a* * e e$d %f &(e)e$*a*!%$. F+"" P(e)c(!b!$g I$f%(#a*!%$ a* ---.OLINVYK.c%#. A5&1"'& NRS P"). S$/1& OLINVYK O-,c(& 0.1 &" 0.35 &" 0.5 &" P%ac b( % C203/)6)( 86% 0% 8?% ?4% % 0/C L0E 11% 3% 5% 22% % !)5'7) M)(5 31% 21% 18% 4 % OLINVYK O-,c(& 0.1 &" 0.35 &" 0.5 &" P%ac b( % C203/)6)( 83% 8?% 84% 60% % 0/C L0E % 4% 5% 34% % !)5'7) M)(5 41% 20% 1?% ??%

 

 

5432-1-ba_corporate_page_36.jpg N3 A''8180%7-32 D)64-7) R)4)%7)( D36-2+ M<3;0-D6:, ; # ";<+@ K*= 6*79187 x 2 %( 3#g e,e(. 2 () 40093 (<;?5@5B1 A ": -//?8?7->5:9 >4<:?34 24 4<= !.*6 %(,I <105: *; 22 7/ 24 8726;: A ": /->13:<5/-7 %(/ :?>751<= C >60 5: >500 5: *+:74<;. A *177 >:71<->10, 9: 'AE=* 92% 9.*,1.-5*? -*24@ -7:. *",) )**)'6 21" 342/21+%6-21 %6 626%/ '707/%6-8) (%-/: (25)5 >2? 0+ ,%5 126 &))1 567(-)( -1 % 6,2427+," 567(: "26%/ '707/%6-8) (%-/: (25)5 )9'))(-1+ 2? 0+ 3)4 (%: 0%: -1'4)%5) 6,) 4-5. *24"' -16)48%/ 342/21+%6-21 ",)4)*24), 6,) '707/%6-8) 626%/ (%-/: (25) 2* 0LIN#$K 5,27/( 126 )9'))( 2? 0+ P"ea)e )ee I#&%(*a$* Safe*. I$f%(#a*!%$ !$c"+d!$g BOXED WARNING a* * e e$d %f &(e)e$*a*!%$. F+"" P(e)c(!b!$g I$f%(#a*!%$ a* ---.OLINVYK.c%#. 3 FH5=86GF ABG 7BF87 7H8 GB ?46> B9 I8ABHF 4668FF7<F6BAG<AH4G<BA 7H8 GB 4 ABA-F8E<BHF 47I8EF8 8I8AG (4FL@CGB@4G<6 ABA-FHFG4<A87 I8AGE<6H?4E G46;L64E7<4 J<G; 6BA9BHA7<A: ;LCB>4?8@<4 4A7 AB @84A<A:9H? ,/ CEB?BA:4G<BA 7HE<A: 7BF<A:, FH5=86G 6B@C?8G87 7BF<A: 5HG ABG 8I4?H45?8 7H8 GB 8DH<C@8AG @4?9HA6G<BA 36 O*)#%/)$),%M-4)&*-4!#), 20 15 10 M%!, 66QT#I 5 (+0%#) [90% CI 0 -5 ?9>11<= -10 -15 0246810 12 14 16 18 20 22 24 T)+% ((-2/0) (2793 9-D)/;:@>;8) " = 68 41-7>4C @:7

 

 

5432-1-ba_corporate_page_37.jpg ln$e"ac$i n Be$&een $he AT1 Rece!$ " and ACE2 in COVlD-19 D6>59,.<3(;065 6-ACE2 )@ *6965(=09<: 05+09,*;3@ 79646;,: (*;0=(;065 6-;/, A#1 9,*,7;69 C C6965(=09<: )05+: ;6 (5+ +6>59,.<3(;,: (5.06;,5:05 *65=,9;05. ,5A@4, 2 (ACE2)1 C D,*9,(:, 05 ACE2 ,3,=(;,: (5.06;,5:05 II 3,=,3: - A6/17;-6:16 II )+;1=);-: A%1 9-+-8;79 - 7 *9-)3,7>6 7. )6/17;-6:16 II 16;7 A6/(1-7) o '@C>2==J, A?8(1-7) 24ED 2D 2 O-2CC6DE:?-3:2D65 =:82?5 2E E96 A-1 C646AE@C2 o )C@E64E:G6 E96C2A6FE:4 36?67:ED :? E96 =F?8D3 3? &H54 & 8G 4?., )4G (87, 2005. 2 /8<K8<E4 'B 8G 4?., .6< -8C, 20 7. 3 .4AGBF -A. 8G 4?., +;LF<B? -8I, 20 . SARS-C-V-2 ACE2 V)/!* %,1/5 !,$ ACE2 $-3,/%'2*!1)-,

 

 

5432-1-ba_corporate_page_38.jpg Del$a Rece $o" Agoni#$# Ha&e Uni!%e Benefi$# P6;,5;0(3 <;030;@ -69 ( =(90,;@ 6-CN" 05+0*(;065: T)#(+a&* I D#+a&* C #(9.,;: :,96;6505 9,*,7;69: 4,+0(;, =(:*<3(9 ,?*0;()030;@ ((::6*0(;,+ C% 90:2)1 C M0.9(05,-:7,*0-0* ;9,(;4,5; CGRP* C #(9.,;: CG!P 9,*,7;69: 9,.<3(;, 5,<965(3 :;9<*;<9,: 05=63=,+ 05 7(05 :0.5(305.2 C M0.9(05,-:7,*0-0* ;9,(;4,5; De$+a )ece(+') a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

 

 

5432-1-ba_corporate_page_39.jpg IMPORTANT SAFETY INFORMATION 3

 

 

5432-1-ba_corporate_page_40.jpg L/2/9'9/438 4, "8+ B+)':8+ 4, 9.+ 7/808 4, '**/)9/43, '(:8+, '3* 2/8:8+ </9. 45/4/*8, +;+3 '9 7+)422+3*+* *48+8, 7+8+7;+ OLIN#$K ,47 :8+ /3 5'9/+398 ,47 <.42 '19+73'9/;+ 97+'92+39 459/438 %+.-., 343-45/4/* '3'1-+8/)8 47 45/4/* )42(/3'9/43 574*:)98&: G H';+ 349 (++3 941+7'9+*, 47 '7+ 349 +=5+)9+* 94 (+ 941+7'9+* G H';+ 349 574;/*+* '*+6:'9+ '3'1-+8/', 47 '7+ 349 +=5+)9+* 94 574;/*+ '*+6:'9+ '3'1-+8/'. !.+ ):2:1'9/;+ 949'1 *'/1> *48+ 8.4:1* 349 +=)++* 27 2-, '8 949'1 *'/1> *48+8 -7+'9+7 9.'3 27 2-2'> /3)7+'8+ 9.+ 7/80 ,47 Q!) /39+7;'1 574143-'9/43. CONTRAINDICATIONS OLIN#$K /8 )4397'/3*/)'9+* /3 5'9/+398 </9.: • /-3/,/)'39 7+85/7'947> *+57+88/43 • A):9+ 47 8+;+7+ (743)./'1 '89.2' /3 '3 :3243/947+* 8+99/3-47 /3 9.+ '(8+3)+ 4, 7+8:8)/9'9/;+ +6:/52+39 • K34<3 47 8:85+)9+* -'8974/39+89/3'1 4(897:)9/43, /3)1:*/3-5'7'1>9/) /1+:8 • K34<3 .>5+78+38/9/;/9> 94 41/)+7/*/3+ (+.-., '3'5.>1'=/8) WARNINGS AND PRECAUTIONS • OLIN#$K )439'/38 41/)+7/*/3+, ' ).+*:1+ [controlled substance schedule pending] )4397411+* 8:(89'3)+, 9.'9 +=548+8 :8+78 94 9.+ 7/808 4, '**/)9/43, '(:8+, '3* 2/8:8+. A19.4:-. 9.+ 7/80 4, '**/)9/43 /3 '3> /3*/;/*:'1 /8 :3034<3, /9 )'3 4)):7 /3 5'9/+398 '557457/'9+1> 57+8)7/(+* OLIN#$K. A88+88 7/80, )4:38+1, '3* 243/947 '11 5'9/+398 7+)+/;/3-45/4/*8. • +7/4:8, 1/,+-9.7+'9+3/3-7+85/7'947> *+57+88/43 .'8 (++3 7+5479+* </9. 9.+ :8+ 4, 45/4/*8, +;+3 <.+3 :8+* '8 7+)422+3*+*, +85+)/'11> /3 5'9/+398 </9. ).743/) 5:1243'7> */8+'8+, 47 /3 +1*+71>, )').+)9/) '3* *+(/1/9'9+* 5'9/+398. !.+ 7/80 /8 -7+'9+89 *:7/3-/3/9/'9/43 4, OLIN#$K 9.+7'5>, ,4114</3-' *48+ /3)7+'8+, 47 <.+3 :8+* </9. 49.+7 *7:-8 9.'9 *+57+88 7+85/7'9/43. P745+7 *48/3-4, OLIN#$K /8 +88+39/'1, +85+)/'11> <.+3 )43;+79/3-5'9/+398 ,742 '349.+7 45/4/* 574*:)9 94 ';4/* 4;+7*48+. M'3'-+2+39 4, 7+85/7'947> *+57+88/43 2'> /3)1:*+ )148+ 4(8+7;'9/43, 8:55479/;+ 2+'8:7+8, '3* :8+ 4, 45/4/* '39'-43/898, *+5+3*/3-43 9.+ 5'9/+39A8 )1/3/)'1 89'9:8. • O5/4/*8 )'3 )':8+ 81++5-7+1'9+* (7+'9./3-*/847*+78 /3)1:*/3-)+397'1 81++5 '53+' (C A) '3* 81++5-7+1'9+* .>54=+2/' </9. 7/80 /3)7+'8/3-/3 ' *48+-*+5+3*+39 ,'8./43. I3 5'9/+398 <.4 57+8+39 </9. C A, )438/*+7 *+)7+'8/3-9.+ *48+ 4, 45/4/* :8/3-(+89 57')9/)+8 ,47 45/4/* 9'5+7. INDICATIONS AND USAGE OLIN#$K /8 ' 3+< ).+2/)'1 +39/9> /3*/)'9+* /3 '*:198 ,47 9.+ 2'3'-+2+39 4, '):9+ 5'/3 8+;+7+ +34:-. 94 7+6:/7+ '3 /397';+34:8 45/4/* '3'1-+8/) '3* ,47 <.42 '19+73'9/;+ 97+'92+398 '7+ /3'*+6:'9+. 40 WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; ,# RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS A##("2(-,, A!31$, ,# M(131$ OLINVYK $6.-1$1 . 2($,21 ,# -2'$0 31$01 2-2'$ 0(1)1 -% -.(-(# ##("2(-,, !31$, ,# +(131$, 5'("' " , *$ # 2--4$0#-1$ ,# #$ 2'. A11$11 $ "' . 2($,291 0(1) !$%-0$ .0$1"0(!(,& OLINVYK, ,# +-,(2-0 ** . 2($,21 0$&3* 0*7 %-0 2'$ #$4$*-.+$,2 -% !$' 4(-01 -0 "-,#(2(-,1. L(%$-T'0$ 2$,(,& R$1.(0 2-07 D$.0$11(-, S$0(-31, *(%$-2'0$ 2$,(,&, -0 % 2 * 0$1.(0 2-07 #$.0$11(-, + 7 -""30 5(2' 31$ -% OLINVYK. M-,(2-0 %-0 0$1.(0 2-07 #$.0$11(-,, $1.$"( **7 #30(,& (,(2( 2(-, -% OLINVYK -0 %-**-5(,& #-1$ (,"0$ 1$. N$-, 2 * O.(-(# W(2'#0 5 * S7,#0-+$ P0-*-,&$# 31$ -% OLINVYK #30(,& .0$&, ,"7 " , 0$13*2 (, ,$-, 2 * -.(-(# 5(2'#0 5 * 17,#0-+$, 5'("' + 7 !$ *(%$-2'0$ 2$,(,& (% ,-2 0$"-&,(8$# ,# 20$ 2$#, ,# 0$/3(0$1 + , &$+$,2 ""-0#(,& 2-.0-2-"-*1 #$4$*-.$# !7 ,$-, 2-*-&7 $6.$021. I% -.(-(# 31$ (1 0$/3(0$# %-0 .0-*-,&$# .$0(-# (, .0$&, ,2 5-+ ,, #4(1$ 2'$ . 2($,2 -% 2'$ 0(1) -% ,$-, 2 * -.(-(# 5(2'#0 5 * 17,#0-+$ ,# $,130$ 2' 2 ..0-.0( 2$ 20$ 2+$,2 5(** !$ 4 (* !*$. R(1) F0-+ C-,"-+(2 ,2 U1$ W(2' B$,8-#( 8$.(,$1 -0 O2'$0 CNS D$.0$11 ,21 C-,"-+(2 ,2 31$ -% -.(-(#1 5(2' !$,8-#( 8$.(,$1 -0 -2'$0 CNS #$.0$11 ,21, (,"*3#(,& *"-'-*, + 7 0$13*2 (, .0-%-3,# 1$# 2(-,, 0$1.(0 2-07 #$.0$11(-,, "-+ , ,# #$ 2'. R$1$04$ "-,"-+(2 ,2 .0$1"0(!(,& %-0 31$ (, . 2($,21 %-0 5'-+ *2$0, 2(4$ 20$ 2+$,2 -.2(-,1 0$ (, #$/3 2$; *(+(2 #-1 &$1 ,# #30 2(-,1 2-2'$ +(,(+3+ 0$/3(0$#; ,# %-**-5 . 2($,21 %-0 1(&,1 ,# 17+.2-+1 -% 0$1.(0 2-07 #$.0$11(-, ,# 1$# 2(-,.

 

 

5432-1-ba_corporate_page_41.jpg WARNINGS AND PRECAUTIONS • P74143-+* :8+ 4, 45/4/*8 *:7/3-57+-3'3)> )'3 7+8:19 /3 </9.*7'<'1 /3 9.+ 3+43'9+ 9.'9 2'> (+ 1/,+-9.7+'9+3/3-. O(8+7;+ 3+<(4738 ,47 8/-38 4, 3+43'9'1 45/4/* </9.*7'<'1 8>3*742+ '3* 2'3'-+ '))47*/3-1>. A*;/8+ 57+-3'39 <42+3 :8/3-OLIN#$K ,47 ' 574143-+* 5+7/4* 4, 9.+ 7/80 4, 3+43'9'1 45/4/* </9.*7'<'1 8>3*742+ '3* +38:7+ 9.'9 '557457/'9+ 97+'92+39 </11 (+ ';'/1'(1+. • P74,4:3* 8+*'9/43, 7+85/7'947> *+57+88/43, )42', '3* *+'9. 2'> 7+8:19 ,742 9.+ )43)42/9'39 :8+ 4, OLIN#$K </9. (+3?4*/'?+5/3+8 47 49.+7 CN *+57+88'398 (+.-., 343-(+3?4*/'?+5/3+ 8+*'9/;+8/.>5349/)8, '3=/41>9/)8, 97'36:/1/?+78, 2:8)1+ 7+1'='398, -+3+7'1 '3+89.+9/)8, '39/58>).49/)8, 49.+7 45/4/*8, 47 '1)4.41). B+)':8+ 4, 9.+8+ 7/808, 7+8+7;+ )43)42/9'39 57+8)7/(/3-4, 9.+8+ *7:-8 ,47 :8+ /3 5'9/+398 ,47 <.42 '19+73'9/;+ 97+'92+39 459/438 '7+ /3'*+6:'9+, 57+8)7/(+ 9.+ 14<+89 +,,+)9/;+ *48+, '3* 2/3/2/?+ 9.+ *:7'9/43. • OLIN#$K <'8 8.4<3 94 .';+ 2/1* Q!) /39+7;'1 574143-'9/43 /3 9.474:-. Q! 89:*/+8 <.+7+ 5'9/+398 <+7+ *48+* :5 94 27 2-. !49'1 ):2:1'9/;+ *'/1> *48+8 +=)++*/3-27 2-5+7 *'> <+7+ 349 89:*/+* '3* 2'> /3)7+'8+ 9.+ 7/80 ,47 Q!) /39+7;'1 574143-'9/43. !.+7+,47+, 9.+ ):2:1'9/;+ 949'1 *'/1> *48+ 4, OLIN#$K 8.4:1* 349 +=)++* 27 2-. • I3)7+'8+* 51'82' )43)+397'9/438 4, OLIN#$K 2'> 4)):7 /3 5'9/+398 </9. *+)7+'8+* C>94).742+ P450 (C$P) 2D6 ,:3)9/43 47 3472'1 2+9'(41/?+78 9'0/3-24*+7'9+ 47 89743-C$P2D6 /3./(/9478; '184 /3 5'9/+398 9'0/3-' 24*+7'9+ 47 89743-C$P3A4 /3./(/947, /3 5'9/+398 </9. *+)7+'8+* C$P2D6 ,:3)9/43 <.4 '7+ '184 7+)+/;/3-' 24*+7'9+ 47 89743-C$P3A4 /3./(/947, 47 </9. */8)439/3:'9/43 4, ' C$P3A4 /3*:)+7. !.+8+ 5'9/+398 2'> 7+6:/7+ 1+88 ,7+6:+39 *48/3-'3* 8.4:1* (+ )148+1> 243/947+* ,47 7+85/7'947> *+57+88/43 '3* 8+*'9/43 '9 ,7+6:+39 /39+7;'18. C43)42/9'39 :8+ 4, OLIN#$K </9. C$P3A4 /3*:)+78 47 */8)439/3:'9/43 4, ' 24*+7'9+ 47 89743-C$P3A4 /3./(/947 )'3 14<+7 9.+ +=5+)9+* )43)+397'9/43, <./). 2'> *+)7+'8+ +,,/)')>, '3* 2'> 7+6:/7+ 8:551+2+39'1 *48+8. • C'8+8 4, '*7+3'1 /38:,,/)/+3)> .';+ (++3 7+5479+* </9. 45/4/* :8+ (:8:'11> -7+'9+7 9.'3 43+ 2439.). P7+8+39'9/43 '3* 8>259428 2'> (+ 34385+)/,/) '3* /3)1:*+ 3':8+', ;42/9/3-, '347+=/', ,'9/-:+, <+'03+88, */??/3+88, '3* 14< (144* 57+88:7+. I, )43,/72+*, 97+'9 </9. 5.>8/414-/) 7+51')+2+39 *48+8 4, )479/)489+74/*8 '3* <+'3 5'9/+39 ,742 9.+ 45/4/*. • OLIN#$K 2'> )':8+ 8+;+7+ .>549+38/43, /3)1:*/3-479.489'9/) .>549+38/43 '3* 8>3)45+ /3 '2(:1'947> 5'9/+398. • !.+7+ /8 /3)7+'8+* 7/80 /3 5'9/+398 <.48+ '(/1/9> 94 2'/39'/3 (144* 57+88:7+ .'8 '17+'*> (++3 )425742/8+* (> ' 7+*:)+* (144* ;41:2+ 47 )43):77+39 '*2/3/897'9/43 4, )+79'/3 CN *+57+88'39 *7:-8 (+.-., 5.+349./'?/3+8 47 -+3+7'1 '3+89.+9/)8). M43/947 9.+8+ 5'9/+398 ,47 8/-38 4, .>549+38/43. I3 5'9/+398 </9. • A8 </9. '11 45/4/*8, OLIN#$K 2'> )':8+ 85'82 4, 9.+ 85./3)9+7 4, O**/, '3* 2'> )':8+ /3)7+'8+8 /3 8+7:2 '2>1'8+. M43/947 5'9/+398 </9. (/1/'7> 97')9 */8+'8+, /3)1:*/3-'):9+ 5'3)7+'9/9/8, ,47 <478+3/3-8>259428. • !.+7+ /8 /3)7+'8+* 7/80 /3 5'9/+398 <.48+ '(/1/9> 94 2'/39'/3 (144* 57+88:7+ .'8 '17+'*> (++3 )425742/8+* (> ' 7+*:)+* (144* ;41:2+ 47 )43):77+39 '*2/3/897'9/43 4, )+79'/3 CN *+57+88'39 *7:-8 (+.-., 5.+349./'?/3+8 47 -+3+7'1 '3+89.+9/)8). M43/947 9.+8+ 5'9/+398 ,47 8/-38 4, .>549+38/43. I3 5'9/+398 </9. )/7):1'947> 8.4)0, ';4/* 9.+ :8+ 4, OLIN#$K '8 /9 2'> )':8+ ;'84*/1'9/43 9.'9 )'3 ,:79.+7 7+*:)+ )'7*/') 4:95:9 '3* (144* 57+88:7+. • A;4/* 9.+ :8+ 4, OLIN#$K /3 5'9/+398 </9. /25'/7+* )438)/4:83+88 47 )42'. OLIN#$K 8.4:1* (+ :8+* </9. )':9/43 /3 5'9/+398 <.4 2'> (+ 8:8)+59/(1+ 94 9.+ /397')7'3/'1 +,,+)98 4, CO2 7+9+39/43, 8:). '8 9.48+ </9. +;/*+3)+ 4, /3)7+'8+* /397')7'3/'1 57+88:7+ 47 (7'/3 9:2478, '8 ' 7+*:)9/43 /3 7+85/7'947> *7/;+ '3* 9.+ 7+8:19'39 CO2 7+9+39/43 )'3 ,:79.+7 /3)7+'8+ /397')7'3/'1 57+88:7+. M43/947 8:). 5'9/+398 ,47 8/-38 4, 8+*'9/43 '3* 7+85/7'947> *+57+88/43, 5'79/):1'71> <.+3 /3/9/'9/3-9.+7'5>. • A8 </9. '11 45/4/*8, OLIN#$K 2'> )':8+ 85'82 4, 9.+ 85./3)9+7 4, O**/, '3* 2'> )':8+ /3)7+'8+8 /3 8+7:2 '2>1'8+. M43/947 5'9/+398 </9. (/1/'7> 97')9 */8+'8+, /3)1:*/3-'):9+ 5'3)7+'9/9/8, ,47 <478+3/3-8>259428. • OLIN#$K 2'> /3)7+'8+ 9.+ ,7+6:+3)> 4, 8+/?:7+8 /3 5'9/+398 </9. 8+/?:7+ */847*+78 '3* 2'> /3)7+'8+ 9.+ 7/80 4, 8+/?:7+8 /3 ;:13+7'(1+ 5'9/+398. M43/947 5'9/+398 </9. ' ./8947> 4, 8+/?:7+ */847*+78 ,47 <478+3+* 8+/?:7+ )439741. • D4 349 '(7:591> */8)439/3:+ OLIN#$K /3 ' 5'9/+39 5.>8/)'11> *+5+3*+39 43 45/4/*8. G7'*:'11> 9'5+7 9.+ *48'-+ 94 ';4/* ' </9.*7'<'1 8>3*742+ '3* 7+9:73 4, 5'/3. A;4/* 9.+ :8+ 4, 2/=+* '-43/89/'39'-43/89 (+.-., 5+39'?4)/3+, 3'1(:5./3+, '3* (:9475.'341) 47 5'79/'1 '-43/89 (+.-., (:57+3475./3+) '3'1-+8/)8 /3 5'9/+398 <.4 '7+ 7+)+/;/3-OLIN#$K, '8 9.+> 2'> 7+*:)+ 9.+ '3'1-+8/) +,,+)9 '3*/47 57+)/5/9'9+ </9.*7'<'1 8>259428. • OLIN#$K 2'> /25'/7 9.+ 2+39'1 47 5.>8/)'1 '(/1/9/+8 3++*+* 94 5+7,472 549+39/'11> .'?'7*4:8 ')9/;/9/+8 8:). '8 *7/;/3-' )'7 47 45+7'9/3-2')./3+7>. • A19.4:-. 8+1,-'*2/3/897'9/43 4, 45/4/*8 (> 5'9/+39-)4397411+* '3'1-+8/' (PCA) 2'> '114< +'). 5'9/+39 94 /3*/;/*:'11> 9/97'9+ 94 '3 '))+59'(1+ 1+;+1 4, '3'1-+8/', PCA '*2/3/897'9/43 .'8 7+8:19+* /3 '*;+78+ 4:9)42+8 '3* +5/84*+8 4, 7+85/7'947> *+57+88/43. H+'19. )'7+ 574;/*+78 '3* ,'2/1> 2+2(+78 243/947/3-5'9/+398 7+)+/;/3-PCA '3'1-+8/' 8.4:1* (+ /3897:)9+* /3 9.+ 3++* ,47 '557457/'9+ 243/947/3-,47 +=)+88/;+ 8+*'9/43, 7+85/7'947> *+57+88/43, 47 49.+7 '*;+78+ +,,+)98 4, 45/4/* 2+*/)'9/438. )/7):1'947> 8.4)0, ';4/* 9.+ :8+ 4, OLIN#$K '8 /9 2'> )':8+ ;'84*/1'9/43 9.'9 )'3 ,:79.+7 7+*:)+ )'7*/') 4:95:9 '3* (144* 57+88:7+. ADVERSE REACTIONS A*;+78+ 7+')9/438 '7+ *+8)7/(+* /3 -7+'9+7 *+9'/1 /3 9.+ P7+8)7/(/3-I3,472'9/43. !.+ 2489 )42243 (/3)/*+3)+ @10%) '*;+78+ 7+')9/438 /3 P.'8+ 3 )4397411+* )1/3/)'1 97/'18 <+7+ 3':8+', ;42/9/3-, */??/3+88, .+'*').+, )4389/5'9/43, 57:7/9:8, '3* .>54=/'. • A;4/* 9.+ :8+ 4, OLIN#$K /3 5'9/+398 </9. /25'/7+* )438)/4:83+88 47 )42'. OLIN#$K 8.4:1* (+ :8+* </9. )':9/43 /3 5'9/+398 <.4 2'> (+ 8:8)+59/(1+ 94 9.+ /397')7'3/'1 +,,+)98 4, CO2 7+9+39/43, 8:). '8 9.48+ </9. +;/*+3)+ 4, /3)7+'8+* /397')7'3/'1 57+88:7+ 47 (7'/3 9:2478, '8 ' 7+*:)9/43 /3 7+85/7'947> *7/;+ '3* 9.+ 7+8:19'39 CO2 7+9+39/43 )'3 ,:79.+7 /3)7+'8+ /397')7'3/'1 57+88:7+. M43/947 8:). 5'9/+398 ,47 8/-38 4, 8+*'9/43 '3* 7+85/7'947> *+57+88/43, 5'79/):1'71> <.+3 /3/9/'9/3-9.+7'5>. 41